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Effects of a modified yeast supplement on cold/flu symptoms

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A yeast-based product (EpiCor, a dried Saccharomyces cerevisiae fermentate) was compared to placebo to determine effects on the incidence and duration of cold and flu-like symptoms in healthy subjects recently vaccinated for seasonal influenza. In a 12-week, randomized, double-blind, placebo-controlled clinical trial, 116 participants received daily supplementation with 500 mg of EpiCor or placebo for 12 weeks. Data collected included periodic in-clinic examinations and serologic evaluations at baseline, 6- and 12-weeks. Subjects also utilized a standardized self-report symptom diary during the study. Participants receiving the yeast-based product had significantly fewer symptoms and significantly shorter duration of symptoms when compared with subjects taking a placebo.
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A yeast-based product (EpiCor
®
, a dried
Saccharomyces cerevisiae
fermentate) was compared to placebo to determine effects on the
incidence and duration of cold and flu-like symptoms in healthy sub-
jects recently vaccinated for seasonal influenza. In a 12-week, ran-
domized, double-blind, placebo-controlled clinical trial, 116 partici-
pants received daily supplementation with 500 mg of EpiCor or place-
bo for 12 weeks. Data collected included periodic in-clinic examina-
tions and serologic evaluations at baseline, 6- and 12-weeks.
Subjects also utilized a standardized self-report symptom diary dur-
ing the study. Participants receiving the yeast-based product had sig-
nificantly fewer symptoms and significantly shorter duration of
symptoms when compared with subjects taking a placebo.
Key Words: Influenza,
Saccharomyces cerevisiae
, yeast, EpiCor,
common cold, flu, dietary supplement.
50 UROLOGIC NURSING / February 2008 / Volume 28 Number 1
I
mmune modulation that
includes suppression or
enhancement of immune
function has become either a
primary or potential form of
adjuvant preventive medical
treatment, and is an ongoing
focus of research (Ault, 2007;
Chiarella, Massi, DeRobertis,
Signon, & Fazio, 2007). For
example, immune suppression is
utilized for more complex dis-
eases, such as rheumatic arthri-
tis, asthma, and inflammatory
bowel disease (Leath, Singla, &
Peters, 2005; Williams, Paleolog,
& Feldmann, 2007). Other condi-
tions, such as allergic reactions,
also require down-regulation of
immune function, usually with
less intensity, and numerous
over-the-counter treatments are
Effects of a Modified Yeast
Supplement on Cold/Flu Symptoms
Mark A. Moyad
Larry E. Robinson
Edward T. Zawada, Jr.
Julie M. Kittelsrud
Ding-Geng Chen
Stuart G. Reeves
Susan E. Weaver
Mark A. Moyad, MD, MPH, is the
Jenkins/Pokempner Director, Preventive and
Alternative Medicine, University of Michigan
Medical Center, Department of Urology, Ann
Arbor, MI.
Larry E. Robinson, PhD, is Vice President,
Scientific Affairs, Embria Health Sciences
Ankeny, IA.
Edward T. Zawada, Jr., MD, is Medical
Director, Avera North Central Kidney
Institute, Sioux Falls, SD.
Julie M. Kittelsrud, MSN, RN, CNP, is a
Nurse Practitioner, Avera Research Institute,
Sioux Falls, SD.
Ding-Geng Chen, PhD, is a Professor,
Department of Mathematics and Statistics,
South Dakota State University, Brookings,
SD.
Stuart G. Reeves, PhD, is Director of
Research and Development, Embria Health
Sciences, Ankeny, IA.
Susan E.Weaver, MSN, RN, CNP, is a Nurse
Practitioner, Avera Research Institute, Sioux
Falls, SD
.
Introduction
Many over-the-counter products
claim to reduce symptoms associated
with cold and flu. This is the largest
randomized trial to date to examine
the impact of a daily modified yeast-
based product (EpiCor
®
, a dried
Saccharomyces cerevisiae
fermen-
tate) compared to placebo on the inci-
dence and duration of cold and flu-like
symptoms in healthy subjects recently
vaccinated for seasonal influenza.
Objective
To determine if a modified yeast-
based dietary supplement (EpiCor)
taken daily reduces the incidence and
duration of colds or flu-like sympto-
matic features in a group of healthy
individuals recently vaccinated against
seasonal flu (influenza).
Design and Method
A 12-week experimental, double-
blind, placebo-controlled study of 116
randomized, healthy participants with
up-to-date vaccination histories
received daily supplementation with
500 mg of EpiCor or placebo for 12
weeks. Clinical outcome measure-
ments included periodic in-clinic
examinations at baseline, 6- and 12-
weeks; participants also utilized a
standardized self-report symptom
diary during the entire study. Com-
prehensive laboratory serologic analy-
sis was performed during each clinic
visit.
Results
Subjects receiving EpiCor experi-
enced a statistically significant reduc-
tion in the incidence (
p
= 0.01) and
duration (
p
= 0.03) of colds or flu com-
pared with participants receiving
placebo. Additionally, subjects in the
EpiCor group experienced a non-sig-
nificant (
p
= 0.23) reduction in adverse
events compared to placebo.
Conclusions
Daily nutritional supplementation
with 500 mg of EpiCor may be an
effective adjuvant preventive treatment
in patients recently vaccinated for sea-
sonal influenza. This yeast-based
intervention also demonstrated a safe-
ty profile similar to a placebo. Future
studies should focus on the use of this
product as a potential single agent to
reduce cold and flu-like symptoms in
healthy individuals.
Level of Evidence – Level II
Do Not Reprint
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UROLOGIC NURSING / February 2008 / Volume 28 Number 1 51
now available (Finegold, 2007).
Enhancement of immune func-
tion also is being investigated
currently as a potential primary
form of medical treatment for
certain types of invasive dis-
eases, such as cancer (Cranmer &
Hersh, 2007; Moyad, 2007a;
O’Neill & Bhardwaj, 2007).
Respiratory infections are
also part of an intense focus on
better preventive therapies. In-
fluenza is now responsible for
more than 200,000 hospitaliza-
tions and approximately 36,000
deaths per year in the U.S. alone
(Lynch & Walsh, 2007; Roxas
& Jurenka, 2007; Zimmerman,
2005), and it is one of the top 10
causes of mortality in men and
women.
However, the incidence and
impact of this ever-changing viral
infection is increasing, which is
potentially due to the current
and ongoing increase in the aging
population. The seasonal vaccine
itself has kept this disease from
becoming a more primary cause
of morbidity and mortality, and
health education concerning the
importance of this vaccine has
been a critical component to
effective preventive medicine.
Concerns about vaccine resist-
ance, waiting periods for novel
annual vaccines, and patient
access issues (regardless of finan-
cial background or insurance sta-
tus) limit its use in many geo-
graphical areas and among differ-
ent population groups.
The common cold is less of a
medical concern; yet, virulent
variants of the common cold are
becoming more common. The
lack of preventive treatment is
perhaps one of the many reasons
this class of virus is responsible
for millions of dollars a year in the
lack of productivity due to conva-
lescence (Roxas & Jurenka, 2007).
Identifying effective adjuvant
preventive therapies synergistic
or complementary to convention-
al treatments may be beneficial
in decreasing the symptoms and
duration of influenza and colds.
A simplistic or complex reason-
ably priced method that en-
hances general immune function
and may reduce a variety of
infections or symptoms, includ-
ing those of the common cold or
influenza, seems to be a reason-
able and ethical option to im-
prove overall health outcomes,
productivity, and general well
being.
Objective
To date, many over-the-
counter options claim signifi-
cance as a potential adjuvant
therapy or sole treatment for
colds and flu-like symptoms, but
few dietary supplements, apart
from vitamin C, have had ade-
quate numbers of clinical trials
conducted (Moyad & Combs,
2007). For example, meta-analy-
ses exist of randomized trials of
vitamin C and its impact on
pneumonia (Hemila & Louhiala,
2007) or the common cold
(Douglas, Hemila, Chalker, &
Treacy, 2007). More over-the-
counter products should be sub-
jected to rigorous double-blind
randomized trials.
Saccharomyces cerevisiae,
better known as baker’s or brew-
er’s yeast, has a long history of
providing some form of immune
protection or health promotion
beyond its commercial applica-
tions (Moyad, 2007b). Modified
forms of this species of yeast
have been shown to be safe in
moderate dosages but may pro-
vide enhanced immune benefits
beyond what is typically capable
in its original form. For example,
one of the largest randomized tri-
als of cancer prevention that
showed benefits seemed to
enhance selenium supplementa-
tion awareness, but the actual
trial utilized a modified yeast
form that included 200 mcg of
selenium, as opposed to seleni-
um by itself (Clark et al., 1996).
Decades-old research shows that
this same principle has already
been applied to other forms of
yeast, but the lack of randomized
trials that included a placebo is
one potential major limitation to
determining whether or not
yeast-based technology has a
future in preventive medicine
(Moyad, 2007b). Therefore, this
research group decided to pro-
vide more clarity on this issue.
This randomized trial is the
largest to date that has examined
the impact of a yeast-based
dietary supplement on the inci-
dence of cold and flu-like symp-
toms, and more specifically, on
the symptoms associated with
these conditions in subjects with
a recent history of seasonal
influenza vaccination.
The primary objective of the
study was to determine if a once-
daily dose of the modified yeast
product would reduce the inci-
dence and duration of the com-
mon cold or influenza-like symp-
toms in healthy human subjects
that had recently received the
influenza vaccine. A second end-
point measured in the study was
the severity of these symptoms if
illness occurred.
Methods
Sample and setting. Individ-
uals were recruited via print
advertisements, local television,
and e-mail. Age range was 18 to
76 years (M = 44, SD = 11) and
included subjects living in a met-
ropolitan area of the rural Mid-
west. The number of participants
at the start of the study totaled
130. There were a total of 14
dropouts during the study,
including 10 in the supplement
group and 4 in the placebo group.
The final analyses were carried
out on the results from 116 par-
ticipants.
Inclusion criteria. Selected
individuals were healthy, with a
Charlson comorbidity of 0 or 1
(Charlson, Szatrowski, Peterson,
& Gold, 1994), based on basic
physical examination by clinical
and research staff and via self-
report. All had recently received
the seasonal influenza vaccine.
Exclusion criteria. Exclusion
criteria are listed in Table 1.
Power Analysis
Power analysis was conduct-
ed prior to the study for the pro-
posed sample size and signifi-
cance level (0.05). Based on the
proposed sample size with
approximately a similar number
of control subjects compared to
the intervention group, the com-
puted power is 0.886. This com-
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52 UROLOGIC NURSING / February 2008 / Volume 28 Number 1
putation results in an 88.6%
probability of identifying a statis-
tically significant difference
between incidence rates for the
control versus the intervention
group, with a 0.05 significance, if
a true difference exists. Final sta-
tistical analysis on the outcomes
utilized a two-way analysis of
variance (ANOVA), with EpiCor
and placebo as treatment factor,
and all symptoms as another fac-
tor. Ninety-five percent confi-
dence intervals (95% CI) were
calculated around each mean
value to determine the appropri-
ate range of accuracy within each
separate clinical outcome.
Protection of human sub-
jects. The clinical study was con-
ducted in accordance with Good
Clinical Practice (GCP) and all
applicable regulatory require-
ments, and was approved by the
Institutional Review Board (IRB)
by the Avera Institutional Review
Board (IRB) for Avera Health
(Sioux Falls, SD).
Procedure
This 12-week, randomized,
double-blind, placebo-controlled
trial was conducted during the
acute period of the year for cold
and flu seasonal symptoms
(December 2006 to March 2007).
Individuals meeting the inclu-
sion criteria and giving informed
consent were screened for a max-
imum of 14 days to determine
baseline standardized laboratory
values, including complete blood
count (CBC), complete metabolic
profile, and other general health
serologic parameters.
All forms of medications
ingested by subjects during
screening or the 12-week study
period were recorded, and any
changes in medications or
dosages were also noted in the
patient chart. Subjects were
encouraged throughout the study
to continue unaltered with their
specific dietary regime, exercise,
alcohol consumption, and all
other behavioral patterns, includ-
ing smoking, throughout the
study period.
Subjects were randomized to
one of two groups. Both groups
demonstrated statistical equiva-
lence at baseline for body mass
index, medication usage, and
smoking status. The following
mean baseline characteristics for
the EpiCor and placebo group
were: age (43 [SD = 10] and 45 [SD
= 13] years, p = 0. 265), BMI (27.8
[SD = 6.6] and 26.7 [SD = 4.7], p =
0.283), and current smoking status
(14% and 20%); 57% of the partic-
ipants were female. There was no
statistical significance between
baseline characteristics of either
group. The experimental group (n
= 52) received daily doses of 500
mg modified yeast-based product
intervention (EpiCor); the control
group (n = 64) received a placebo.
EpiCor is a dietary supple-
ment, as defined by the Dietary
Supplement and Health Edu-
cation Act (DSHEA) of 1994 (U.S.
Food & Drug Administration,
2007) and was developed by
Embria Health Sciences, LLC., of
Ankeny, IA. It consists of a fer-
mented medium of Saccharo-
myces cerevisiae, which when
proliferating under stress secretes
multiple bioactive metabolites.
Over the last 60 years, a feed addi-
tive product for commercial ani-
mals based on this proprietary
technology has been utilized to
enhance immune function and to
prevent disease. Recently, the
human-modified version of this
product (EpiCor) has been subject
to multiple laboratory safety, sta-
bility, and efficacy investigations.
For example, EpiCor has demon-
strated anti-inflammatory proper-
ties with the stimulation of B lym-
phocytes and natural killer (NK)
cells (Jensen, Hart, & Schauss,
2007).
The placebo capsule was of a
similar appearance, weight, and
non-odor as the active interven-
tion. Subjects were instructed to
ingest medications with breakfast.
Participants attended the research
institute clinic at weeks 0 (base-
line), 6, and 12, and in addition to
examination, were required to
record cold and flu-like symptoms
at home in a modified standard-
Table 1.
Exclusion Criteria Utilized Before Determination of Randomization
in the Cold and Flu Study of the Modified Yeast-Based Product
Compared to Placebo
Diagnosed or treated immune abnormality
Current use of any immunosuppressive medication (such as azathioprine,
cyclosporine, and steroids)
Current use of any antiviral medication (including amantadine, oseltamivir,
rimantadine, and zanamivir)
HIV positive
ALT, AST, BUN, and/or creatinine laboratory values greater than 2 times the
upper limit of normal
Females who are pregnant or breastfeeding, or who are planning to become
pregnant during the study period
History of substance abuse
Severe co-morbidity or concomitant disease or condition
Allergies to yeast or to yeast-derived products
Environmental allergies requiring medication or allergy-based injection therapy
Vitamin deficiency that requires supplementation
Herbal or supplemental preparation use such as echinacea, vitamin C, or zinc
Received seasonal influenza vaccination for 2006 to 2007 period, and more
than 60 days have elapsed between vaccination and the randomization
period
Unable or unwilling to comply with the study protocol (including ingesting the
study supplement or placebo, regular blood sampling, and completing the
study diary)
Current participation in another clinical research investigation of any kind
Do Not Reprint
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UROLOGIC NURSING / February 2008 / Volume 28 Number 1 53
ized diary (McDowell, 2006) pro-
vided by the research group.
Blood samples, basic physical
examination, vital signs (blood
pressure, heart rate, temperature,
and weight), medication, health
summaries (including an on-site
completed Short Form 36 [SF-36])
(Patel, Donegan, & Albert, 2007;
Ware, & Sherbourne, 1992), and
summarized diary information
were preformed and collected at
each clinic visit.
The diagnosis of common
cold or influenza-like symptoms
was primarily based on the pro-
vided self-report diaries (see
Figure 1). Common cold was
clinically defined as an upper
respiratory tract infection of viral
etiology consisting of one or
more of the following symptoms:
cough, generalized malaise,
headache, hoarseness, low-grade
fever, nasal drainage, nasal stuffi-
ness, and sore throat (Centers for
Disease Control and Prevention,
2007).
Influenza-like symptoms were
clinically defined as a respiratory
tract infection of viral etiology
and acute onset, more severe
than the common cold, and con-
sisting of one or more of the fol-
lowing symptoms: chest discom-
fort, fever of 102 to 105 degrees
Fahrenheit, myalgia, nonproduc-
tive cough, prominent headache,
rhinitis, and sore throat (Centers
for Disease Control and
Prevention, 2007). Cold and flu-
like symptoms could clinically
overlap or occur simultaneously.
The incidence of cold or flu-
like symptoms was defined as the
number of clinical occurrences
reported during the entire 12-
week study period. Duration of
symptoms was defined as the
number of consecutive illness
days, and severity was also
recorded on a scale from 0 to 10
as described by the diary.
Adverse events (AE) were
defined as any clinically unfa-
vorable and unintended sign or
laboratory finding, symptom, or
new or exacerbated disease cor-
related with the utilization of the
interventional supplement or
placebo. A serious adverse event
(SAE) was defined as any med-
ical occurrence that included at
least one of the following condi-
tions: life-threatening, requiring
hospitalization, or resulting in
disability, incapacity, or death
during the time of the entire 12-
week trial period. Study medical
staff analyzed each participant’s
past and current health and ill-
ness history to determine if any
incident or prevalent AE was
attributed to a pre-existing condi-
tion or a current illness unrelated
or associated to the study med-
ications. An overview of the
diversity of the symptoms pro-
vided in this diary to evaluate
cold and flu symptoms is provid-
ed in Figure 1.
Results
EpiCor significantly reduced
the incidence and duration of the
common cold or flu-like symp-
toms compared to placebo.
Incidence was significantly (p =
0.011) reduced from a mean of
1.42 (95% CI 1.32 to 15.3) to 1.26
Figure 1.
The Standardized Diary to Evaluate Incidence, Duration, and Severity of Cold and Flu-like Symptoms
As soon as you start noticing any symptoms of cold or influenza, please fill in the diary.
DATE____________
Please assess all symptoms. Circle the number from 0-10
according to how you would rate your symptoms.
0= no symptoms, 10= most severe symptoms.
HEADACHE 0 1 2 3 4 5 6 7 8 9 10
GENERAL ACHES/PAINS 0 1 2 3 4 5 6 7 8 9 10
FATIGUE 0 1 2 3 4 5 6 7 8 9 10
WEAKNESS 0 1 2 3 4 5 6 7 8 9 10
NASAL STUFFINESS 0 1 2 3 4 5 6 7 8 9 10
NASAL DRAINAGE 0 1 2 3 4 5 6 7 8 9 10
SORE THROAT 0 1 2 3 4 5 6 7 8 9 10
COUGH 0 1 2 3 4 5 6 7 8 9 10
HOARSENESS 0 1 2 3 4 5 6 7 8 9 10
CHEST DISCOMFORT 0 1 2 3 4 5 6 7 8 9 10
CHILLS 0 1 2 3 4 5 6 7 8 9 10
FEVER ____________________°F
OTHER SYMPTOMS
(please list)
_______________
0 1 2 3 4 5 6 7 8 9 10
No
symptoms
Most severe
symptoms
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54 UROLOGIC NURSING / February 2008 / Volume 28 Number 1
(95% CI 1.18 to 1.33) clinical
occurrences, and this result
remained significant regardless
of baseline status, including age
(p = 0.54) or gender (p = 0.94).
Duration was also significantly
(p = 0.028) reduced from 5.01 to
4.16 symptom days (95% CI 3.66
to 4.66) compared to a placebo
mean of 5.01 with placebo (95%
CI 4.40 to 5.62), and this result
also remained significant regard-
less of baseline status including
age (p = 0.63) or gender (p=0.34).
Severity increased significantly
(p = 0.002) from 3.17 (95% CI
2.98 to 3.37) to 3.84 (95% CI 3.58
to 4.11). EpiCor in particular had
a significantly greater reducing
impact on several specific symp-
toms compared to placebo,
including incidence of hoarse-
ness (p = 0.008), incidence of
nasal stuffiness (p = 0.008), and
duration in weakness (p = 0.008).
No abnormalities were found
with any of the laboratory serolog-
ic parameters when comparing
EpiCor at baseline to EpiCor at 12
weeks, or when comparing EpiCor
to placebo.
The rate of reporting AEs was
30.8% for EpiCor and 39.1% for
the placebo group, which is a non-
significant difference (p = 0.232).
No serious AEs were reported for
subjects receiving the interven-
tional dietary supplement. How-
ever, two serious AEs were report-
ed in the placebo group: one hos-
pitalization for pneumonia and
one hospitalization for bowel
obstruction in a subject with a past
history of this condition. Both sub-
jects recovered without incident
and both were withdrawn from
the study upon the advice of their
primary care physicians.
Discussion
The results of this, the largest
randomized trial of a modified
yeast-based product, at least ini-
tially espouses the previous obser-
vations and data surrounding the
background information on this
Saccharomyces cerevisiae prod-
uct. Both incidence and duration
of cold and flu-like symptoms
were significantly reduced,
including almost a full day of
duration reduction when harbor-
ing cold and flu-like symptoms.
The accuracy and pertinence of
these significant clinical findings
are further enhanced when the
95% CIs were evaluated because
of the narrow range in the mean of
each of these findings. However,
the small but significant difference
in severity seemed less clinically
relevant because this clinical fea-
ture is more difficult to capture
based on the inherent subjectivity
of severity as an endpoint in a
variety of infectious diseases
(Ioachimescu, Ioachimescu, &
Iannini, 2004).
Strengths
The strengths of this study,
especially for a dietary supple-
ment, are not only numerous but
impressive. The large number of
participants, randomization of
group assignment, maintenance of
the double-blind, and the use of
placebo as a control are features
that set a novel standard, which is
not commonly observed in over-
the-counter product studies. In
addition, the strict exclusion and
inclusion criteria, and the real-
world setting of utilizing a product
in an adjuvant setting further
establish the integrity of the obser-
vations. Finally, the enormous
financial cost (approximately a
quarter of a million dollars) to con-
duct such a clinically robust trial
is further testimony to the inves-
tigative team and the manufactur-
er of this product and hopefully
continues to establish a new para-
digm in the dietary supplement
industry.
Limitations
The limitations of this study
should also be emphasized. More
frequent clinical visits, albeit cost-
ly, would have allowed for closer
follow up and more precise sero-
logic observations. The standard-
ized diary is an imperfect system
of measure but was reviewed with
each visit. Additional immunolog-
ic plasma, serum, urine, and imag-
ing studies could have further
enhanced the accuracy of the trial,
including the duration and severi-
ty data. However, it should be reit-
erated that the monitoring of
primary symptoms in the case of
colds and flu-like symptoms
remains the gold standard for pri-
mary outcome measures utilized
in conventional medical prescrip-
tion drug and vaccine trials
(Eccles, 2005). Thus, the research
team subsequently decided to
mimic these outcome measure-
ments to not only determine con-
ventional effectiveness but also to
further enhance the integrity of
this study.
Conclusion
EpiCor, a modified yeast-
based (Saccharomyces cerevisiae)
dietary supplement taken daily,
appears to significantly reduce the
incidence and duration of cold
and flu-like symptoms when com-
pared to placebo in subjects vacci-
nated for seasonal influenza. This
is also the largest randomized
placebo-controlled trial to date to
demonstrate that a yeast-based
product, acting as an adjuvant
intervention to a conventional
therapy, may improve immune
surveillance and outcomes in an
otherwise healthy population. An
additional trial of EpiCor alone
compared to placebo, regardless of
vaccine status, has also been initi-
ated due to the promising out-
comes with this over-the-counter
intervention.
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... 15,16 EpiCor postbiotic has been demonstrated to improve immune function in healthy adults, lessening the impact or incidence of cold/flu-like or allergy symptoms. [17][18][19] However, the effects of postbiotic supplementation on immune function in the developing immune systems of children are not well understood. The objective of this study was to investigate the efficacy and safety of 84-day supplementation of EpiCor on the incidence of cold/flu symptoms among children aged 4-12 years. ...
... A dose of 500 mg/day EpiCor was chosen based on the safety and efficacy established in a previous adult study showing a high rate of compliance to study product. 19 Compliance to EpiCor was greater than 90%, demonstrating acceptance from younger individuals who may be more particular with the food products they consume. Daily oral supplementation with 500 mg EpiCor, in a gummy format, for 84 days did not significantly reduce the incidence of cold/flu symptoms but resulted in significantly lower overall cold/flu severity compared to Placebo, demonstrating a beneficial effect of EpiCor on immune function in children. ...
... In this study, there was no significant difference in the incidence of cold/flu symptoms between study groups, in contrast with previous research in adults. Previous randomized controlled trials conducted in adults over a 12-week study period demonstrated the beneficial effects of EpiCor postbiotic supplementation on cold/flu symptoms with reduced incidence 18,19 and duration of cold/flu symptoms. 19 Furthermore, adults supplemented with EpiCor had significantly fewer symptoms 19 and a reduction in overall risk or incidence of cold/flu symptoms of more than 90% compared to placebo. ...
Article
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Background Children attending school/daycare are at high risk of acute respiratory tract infections. EpiCor TM postbiotic, derived from yeast fermentate, has been demonstrated to improve immune function in adults, reducing the incidence of cold/flu-like or allergy symptoms. As such, studies are warranted in children as available pharmaceutical options have unwanted side effects. Methods Two-hundred and fifty-six children aged 4–12 years attending school/daycare were randomized to either EpiCor or Placebo for 84 days during the 2022–2023 flu season in Ontario, Canada. The Canadian Acute Respiratory Illness and Flu Scale (CARIFS) and study diary assessed the incidence and severity of cold/flu symptoms and the use of cold/flu medications. Adverse events were recorded. Results Total CARIFS severity scores, ‘sore throat’ and ‘muscle aches or pains’ symptom scores in the EpiCor group were significantly lower compared to Placebo during incidences of cold/flu ( P ≤ 0.05). Participants taking Placebo were 1.73 times more likely to use cold/flu medication compared to those receiving EpiCor ( P = 0.04). The incidence of cold/flu symptoms was not significantly different between groups. EpiCor was found to be safe and well-tolerated. Conclusions EpiCor supplementation resulted in significantly lower cold/flu symptom severity and less cold/flu medication usage than Placebo demonstrating a beneficial effect on immune function in children. Impact Children are at high risk of acquiring cold/flu infections and safe and efficacious mitigating regimens are lacking. Children supplemented daily with 500 mg EpiCor TM postbiotic derived from yeast fermentate had significantly lower overall cold/flu symptom severity, and severity of sore throat and muscle aches or pains over the 84-day supplementation period. EpiCor supplementation resulted in decreased use of traditional cold/flu medication. Daily supplementation with 500 mg of EpiCor for 84 days was safe and well tolerated by healthy children aged 4–12 years attending school or daycare.
... Публикации сочат, че употребата на модифициран ферментат от Saccharomyces cerevisiae (EpiCor®) дава допълнителни ползи при ваксинирани пациенти по отношение на остра вирусна инфекция и грипоподобни симптоми, като значително намалява честотата и тежестта им [16]. ...
... В рандомизирано двойносляпо клинично проучване EpiCor® е модулирал чревната микробиота и е подобрил стомашно-чревния дискомфорт [16]. ...
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Въведение. Острите респираторни инфекции и острите вирусни гастроентерити са често срещани заболявания в първичната помощ В повечето случаи те са самоограничаващи се, но със значима заболеваемост при деца, по-възрастни и имунокомпрометирани пациенти. Публикации сочат, че употребата на модифициран ферментат от Saccharomyces cerevisiae дава допълнителни ползи при по отношение на остра вирусна инфекция, грипо-подобни симптоми, модулиране чревната микробиота и подобряване на стомашно-чревния дискомфорт. Целта на настоящото проучване е да оцени намаляването на продължителността и/или тежестта на инфекциите на горни дихателни пътища (ИГДП) и/или гастроинтестинални вирусни инфекции (ГИВИ) при пациенти, приемащи хранителна добавка със съдържание иновативна биоактивна форма на витамин С (Nutra-C™), натурален комплекс Epicor® (модифициран ферментат от Saccharomyces cerevisiae), ± цинк и витамин D, както и да се оцени броя на епизодите с поява на симптоми през време на наблюдението. Материал и методи. Проведено е интервенционално проучване с 50 пациента с ИГДП и/или ГИВИ, проследени със стандартизиран въпросник за наличието и интензитета на специфични симптоми на ден 0, ден 7 и ден 30. Пациентите приемат добавката като сироп или капсули от ден 0 според начина за употреба на съответните продукти. Резултати. Сърдечната честота и броят вдишвания намаляват значимо между 0 и 7 ден, докато телесната температура на пациентите – при сравняване на всяка двойка от изследваните времеви точки: 0, 7 и 30 ден. На 7-ия ден за симптоми са съобщили 72,0%, а между 7 и 30-тия ден нов епизод са имали 10,2% (само един епизод). Самооценката на физическото здраве на пациентите показва значимо подобрение между 0 и 7 ден, но не се установи динамика между 7 и 30 ден. При пациентите с продължаваща симптоматика на 7 ден се наблюдава значима промяна към подобрение. При пациентите без симптоми на 7-мия ден те са престанали за най-много 8 дни и най-кратко за 4 дни. Заключение. В нашето проучване открихме положителен ефект на хранителната добавка върху протичането на инфекциите на горни дихателни пътища и гастроинтестиналните вирусни инфекции в проследената група. Ключови думи: модифициран ферментат от Saccharomyces cerevisiae, иновативна биоактивна форма на витамин С , инфекция на горни дихателни пътища, гастроинтестинална вирусна инфекция * Introduction. Acute respiratory infections and acute viral gastroenteritis are common diseases in primary care. In most cases, they are self-limiting, but with significant morbidity in children, the elderly, and immunocompromised patients. Publications indicate that the use of a modified ferment from Saccharomyces cerevisiae provides additional benefits in terms of cold, flu-like symptoms, modulation of the gut microbiota, and improvement of gastrointestinal discomfort. The aim of the present study was to evaluate the reduction in duration and/or severity of upper respiratory tract infections (URIs) and/or gastrointestinal viral infections (GIVI) in patients taking dietary supplements containing an innovative bioactive form of vitamin C (Nutra-C™), natural complex Epicor® (modified fermentate from Saccharomyces cerevisiae), ± zinc and vitamin D, and to assess the number of episodes of symptom onset during follow-up. Material and methods. An interventional study is conducted with 50 recruited patients with IGDP and/or GIVI followed by a standardized questionnaire on the presence and intensity of specific symptoms on day 0, day 7, and day 30. Patients take the supplement as syrup capsules from day 0 according to the way of use of the respective products. Results. The heart rate and the number of breaths decrease significantly between the 0th and 7th days, while the body temperature of the patients – when comparing each pair of the investigated time points: 0th, 7th, and 30th days. On the 7th day, symptoms are reported by 72.0%, and between days 7 and 30, a new episode is experienced by 10.2% (only one episode). The patients' physical health self-assessment shows a significant improvement between the 0th and 7th days, but no dynamic is proven between the 7th and 30th days. In the patients with continuing symptoms on day 7, a significant change towards improvement is observed. In patients without symptoms on day 7, they disappear for a maximum of 8 and a minimum of 4 days. Conclusion. We found a positive effect of the investigated food supplement on the course of upper respiratory tract infections and gastrointestinal viral infections within the following group. Keywords: modified fermentate from Saccharomyces cerevisiae, innovative bioactive form of vitamin C, upper respiratory tract infection, gastrointestinal viral infection
... Considering the critical role of protein in pet foods, and in response to consumer demand, sourcing constraints and sustainability concerns, research for novel protein sources have emerged as an important trend in the pet food industry. Dried whole-cell yeast (S. cerevisiae) is an alternative to conventional animal-derived protein sources that aligns with this trend and has been shown to have beneficial health effects in several animal species, including the modulation of the colonic microbiota in dogs (13)(14)(15)(16). Insect based proteins are also tested in dogs wherein the diets were shown to alter the gut microbiota slightly (17). ...
Article
Full-text available
Sustainability concerns have increased consumer demand for non-animal-derived proteins and the search for novel, alternative protein sources. The nutritional sustainability of the food system without compromising the nutrient quality, composition, digestibility and consumption is pivotal. As with farmed livestock, it is imperative to ensure the well-being and food security of companion animals and to develop sustainable and affordable pet foods. The current pilot study was conducted to determine the effect of greenhouse gas-derived novel, fermented protein ingredient in beagle dogs. The greenhouse gas-derived fermented protein is an alternative protein ingredient with optimal nutritional factors and provides traceability, significantly optimizes the use of land and water, and provides sustainability to the feed value chain of canine diets. Three experimental groups including control, 5 and 10% inclusion of high protein ingredients were included in the study and the results suggest that the fermented protein is palatable and acceptable at 5 and 10% inclusions in the diets of dogs. The present study shows no significant difference in general alertness, clinical symptoms, water consumption and social behavior of dogs between 5 and 10% fermented protein inclusion in canine diets. The diversity of the bacterial community did not change after supplementation with the tested protein source in dogs. Only a few bacterial genera differed significantly in relative abundance between the experimental groups. Feed consumption, faecal scoring and the microbiome data results of this pilot study on the use of novel, methane gas derived, bacterial SCP as a protein ingredient in the canine diets, would pave way for more and more inclusion of such novel alternative protein sources in the pet food industry.
... It also protects gut barrier function and gut mucosa structure 18,19 and can induce antiinflammatory effect 20,21 . As both these ingredients have the capability to modulate gut microbiota function, their health promoting effects are both local and systemic [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] . ...
Article
Full-text available
Mild and persisting gastrointestinal symptoms (MPGS) as bloating, constipation or diarrhea are widespread in older adults and often accompanied by gut microbiota dysbiosis. Nutritional interventions help to regulate and restore microbiota and gut function. In this non-randomized continuous prospective cohort study, we evaluated the effects of a 21-day intervention using a dietary dairy-based supplement (AGIJOY™) on self-reported gastrointestinal (GI) symptoms, fecal microbiota composition and short chain fatty acids (SCFA) levels in a cohort of Chinese adults (N = 46, age 27–73) suffering from MPGS. Questionnaire data and fecal samples were collected at baseline (D0), on day 7 and 21 of intervention (D7 and D21). The results showed significant improvement in the self-reported GI symptoms on D21 and a gradual shift in the fecal microbiota composition. In the first week of intervention, the relative abundance (RA) of fecal bifidobacteria significantly increased and the RA of Bacteroides and Helicobacter decreased (p < 0.05). The levels of fecal SCFA remained unchanged during the study. To our knowledge, this is the first study testing the effect of this prebiotic and postbiotic containing milk-based supplement blend on gut microbiota and MPGS among Chinese population under a real living environment.
... Novel protein sources have emerged as an important trend in the pet food industry in response to consumer demand, sourcing constraints, and sustainability concerns. Dried whole-cell yeast (S. cerevisiae) is an alternative to traditional protein sources (i.e., animal-derived protein) that aligns with this trend and has been shown to have beneficial health effects in several animal species, including the modulation of the colonic microbiota in dogs (Moyad et al., 2008;Stercova et al., 2016;Lin et al., 2019). ...
Article
Full-text available
Global protein shortages and sustainability concerns have increased consumer demand for non-animal-derived protein. Dried whole-cell yeast (Saccharomyces cerevisiae) may be a suitable alternative to rendered protein meals in pet foods. The objective of this study was to investigate the effects of dried yeast in dog and cat foods on indicators that pet parents typically use to evaluate the suitability of a food for their pet. For this evaluation, two dog and two cat dry extruded diets were formulated. For each species, the test diet contained 10% dried yeast (Yeast) and the control diet was devoid of yeast (Control). Palatability, apparent total tract nutrient digestibility, and fecal quality of the foods were assessed in dogs and cats. Urine pH and specific gravity were measured in cats as indicators of urinary tract health. In dogs, the Yeast diet showed equivalent or better palatability compared to the Control diet based on total food consumption (P = 0.06), average daily consumption (day 1, P = 0.10; day 2, P = 0.54), and first choice preference over 2 consecutive days (P = 0.005). Cats showed a strong preference for the Yeast diet with more than double the consumption during the 2-d test period (P = 0.001). More cats showed a first-choice preference for the Yeast diet (24 vs. 16), but the difference was not statistically significant (P = 0.21). There were no significant differences in stool quality or nutrient digestibility when fed Yeast vs. Control diets to the dogs and cats (P > 0.05). All cats produced urine with pH and specific gravity values within the normal range, though specific gravity was lower in the Control group (P = 0.003). This study provides support for the acceptability and digestibility of dog and cat diets containing dried yeast as an alternative protein source.
... A fermentate generally refers to "a powdered preparation, derived from a fermented [food] product and which can contain the fermenting microorganisms, components of these microorganisms, culture supernatants, fermented substrates, and a range of metabolites and bioactive components" [163]. For example, an oral fermentation product known as EpiCor, derived from Saccharomyces cerevisiae (S. cerevisiae), showed the potential of enhancing the immune system to protect and aid in defense against cold/flu-like symptoms [164,165]. In these two 12-week randomized, double-blind, placebo-controlled trials, it was proven that this oral over-the-counter fermentate has the ability to reduce the incidence of cold and flu-like symptoms in both individuals with and without a history of influenza vaccination [165]. ...
Article
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In recent times, the emergence of viral infections, including the SARS-CoV-2 virus, the monkeypox virus, and, most recently, the Langya virus, has highlighted the devastating effects of viral infection on human life. There has been significant progress in the development of efficacious vaccines for the prevention and control of viruses; however, the high rates of viral mutation and transmission necessitate the need for novel methods of control, management, and prevention. In recent years, there has been a shift in public awareness on health and wellbeing, with consumers making significant dietary changes to improve their immunity and overall health. This rising health awareness is driving a global increase in the consumption of functional foods. This review delves into the benefits of functional foods as potential natural means to modulate the host immune system to enhance defense against viral infections. We provide an overview of the functional food market in Europe and discuss the benefits of enhancing immune fitness in high-risk groups, including the elderly, those with obesity, and people with underlying chronic conditions. We also discuss the immunomodulatory mechanisms of key functional foods, including dairy proteins and hydrolysates, plant-based functional foods, fermentates, and foods enriched with vitamin D, zinc, and selenium. Our findings reveal four key immunity boosting mechanisms by functional foods, including inhibition of viral proliferation and binding to host cells, modulation of the innate immune response in macrophages and dendritic cells, enhancement of specific immune responses in T cells and B cells, and promotion of the intestinal barrier function. Overall, this review demonstrates that diet-derived nutrients and functional foods show immense potential to boost viral immunity in high-risk individuals and can be an important approach to improving overall immune health.
... Vitamin C and garlic reduce the duration and severity of colds while also boosting the immune system. 61,62 Yoghurt ingestion has been shown to raise the synthesis of cytokines, principally interferon γ, and enhance monocyte cytokine production. 10,16 Probiotics boost innate immunity by improving natural killer cell activity. ...
Article
Full-text available
Due to the absence of successful therapy, vaccines for protection are continuously being developed. Since vaccines must be thoroughly tested, viral respiratory tract infections (VRTIs), mainly coronaviruses, have seriously affected human health worldwide in recent years. In this review, we presented the relevant data which originated from trusted publishers regarding the practical benefits of functional foods (FFs) and their dietary sources, in addition to natural plant products, in viral respiratory and COVID-19 prevention and immune-boosting activities. As a result, FFs were confirmed to be functionally active ingredients for preventing COVID-19 and VRTIs. Furthermore, the antiviral activity and immunological effects of FFs against VRTIs and COVID-19 and their potential main mechanisms of action are also being reviewed. Therefore, to prevent COVID-19 and VRTIs, it is critical to identify controlling the activities and immune-enhancing functional food constituents as early as possible. We further aimed to summarize functional food constituents as a dietary supplement that aids in immune system boosting and may effectively reduce VRTIs and COVID-19 and promote therapeutic efficacy.
Article
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Scientific advancements in understanding the impact of bioactive components in foods on the gut microbiota and wider physiology create opportunities for designing targeted functional foods. The selection of bioactive ingredients with potential local or systemic effects holds promise for influencing overall well-being. An abundance of studies demonstrate that gut microbiota show compositional changes that correlate age and disease. However, navigating this field, especially for non-experts, remains challenging, given the abundance of bioactive ingredients with varying levels of scientific substantiation. This narrative review addresses the current knowledge on the potential impact of the gut microbiota on host health, emphasizing gut microbiota resilience. It explores evidence related to the extensive gut health benefits of popular dietary components and bioactive ingredients, such as phytochemicals, fermented greens, fibres, prebiotics, probiotics, and postbiotics. Importantly, this review distinguishes between the potential local and systemic effects of both popular and emerging ingredients. Additionally, it highlights how dietary hormesis promotes gut microbiota resilience, fostering better adaptation to stress—a hallmark of health. By integrating examples of bioactives, this review provides insights to guide the design of evidence-based functional foods aimed at priming the gut for resilience.
Chapter
The respiratory system, like the gut, harbors a vast variety of microorganisms which include bacteria, viruses and fungi. The advent of next generation sequencing and multi-omic approaches has revealed the diversity and functional significances of microorganisms in the respiratory health. It has been identified that there has been a co-evolution of indigenous respiratory microbiota and the human immune system. However, an immune response is usually generated when the homeostasis of the microbiota is disturbed. The respiratory microbiome has been identified to be important in shaping the respiratory immunity. Gut microbiota and oral microbiota are also known to be pivotal in shaping the immune system of the respiratory tract and influence its microbial dynamics. Proteobacteria, Firmicutes, and Bacteroidetes have been identified to be predominant in the respiratory system. While, Streptococcus, Prevotella, Fusobacteria, and Veillonella forms the major part, potential pathogens, such as Haemophilus and Neisseria, also form a small fraction of the healthy lung microbiome. Dysbiosis of respiratory microbiome can lead to increased colonization of opportunistic pathogens that can lead to respiratory infections such as pneumonia. This chapter describes the microbial diversity of respiratory system and the role of respiratory microbiome during respiratory infections like pneumonia. The chapter also discusses few strategies that have been proved effective in preventing pneumonia.
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The aim of this study was to evaluate the immunomodulating effects of a consumable yeast-based immunogen, EpiCor, on human leukocytes in vitro. The selection of antiinflammatory and lymphocyte activation assays was based on initial evidence for immunomodulating effects of EpiCor from an unusually low incidence of influenza among employees in a factory manufacturing EpiCor, along with a high oxygen radical absorbance capacity value. In the present study, EpiCor significantly reduced the production of reactive oxygen species by neutrophils (P < .005). EpiCor treatment of peripheral blood mononuclear cells (PBMCs) caused induction of the activation markers CD80 and CD86 on B lymphocytes, and CD69 and CD25 on CD3−CD56+ natural killer cells. This induction was also seen on enriched populations of natural killer and B lymphocytes, suggesting a direct effect not dependent on bystander cells. Coculturing of PBMC with EpiCor and phytohemagglutinin resulted in inhibition of phytohemagglutinin-induced T-cell proliferation and reduction of interferon gamma production. Fucoidan, a ligand for the homing molecule l-selectin (CD62L), is known to induce rapid up-regulation of several chemokine receptors on lymphocytes. EpiCor caused strong inhibition of Fucoidan-mediated expression of the chemokine receptors CXCR4 and CCR9 on PBMC. This suggested rapid altering of signal transduction pathways, or a direct competition for cell surface receptors, with an end result being an altered sensitivity to chemotactic signals from tissue. We conclude that EpiCor possesses significant antiinflammatory activity and induces direct activation and increased chemotactic awareness of lymphocyte subsets in vitro. This suggests further study of effects of EpiCor consumption on antiviral defense mechanisms and antibody production.
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A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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The use of patient-derived, objective outcome measures has expanded substantially within the orthopaedic literature. Quality-of-life instruments are categorized as general health or as condition-specific questionnaires. The Medical Outcomes Study 36-Item Short Form (SF-36) is a general health-based survey of quality of life. it has been validated, is used widely across medical disciplines, and can be self-administered by the patient with reliability. The SF-36 has been implemented to define disease conditions, to determine the effect of treatment, to differentiate the effect of different treatments, and to compare orthopaedic conditions with other medical conditions. However, a bias of lower over upper extremity function has been demonstrated with the SF-36, as have limitations in assessment of certain physical activities of daily living as well as upper and lower limits on the detection of certain changes in quality-of-life status. Nevertheless, with an adequate knowledge of its effectiveness and limitations, the SF-36 can be a useful tool in many branches of orthopaedic surgery.
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The basic objective of this paper is to evaluate an age-comorbidity index in a cohort of patients who were originally enrolled in a prospective study to identify risk factors for peri-operative complications. Two-hundred and twenty-six patients were enrolled in the study. The participants were patients with hypertension or diabetes who underwent elective surgery between 1982 and 1985 and who survived to discharge. Two-hundred and eighteen patients survived until discharge. These patients were followed for at least five years post-operatively. The estimated relative risk of death for each comorbidity rank was 1.4 and for each decade of age was 1.4. When age and comorbidity were modelled as a combined age-comorbidity score, the estimated relative risk for each combined age-comorbidity unit was 1.45. Thus, the estimated relative risk of death from an increase of one in the comorbidity score proved approximately equal to that from an additional decade of age. The combined age-comorbidity score may be useful in some longitudinal studies to estimate relative risk of death from prognostic clinical covariates.
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To determine whether a nutritional supplement of selenium will decrease the incidence of cancer. A multicenter, double-blind, randomized, placebo-controlled cancer prevention trial. Seven dermatology clinics in the eastern United States. A total of 1312 patients (mean age, 63 years; range, 18-80 years) with a history of basal cell or squamous cell carcinomas of the skin were randomized from 1983 through 1991. Patients were treated for a mean (SD) of 4.5 (2.8) years and had a total follow-up of 6.4 (2.0) years. Oral administration of 200 microg of selenium per day or placebo. The primary end points for the trial were the incidences of basal and squamous cell carcinomas of the skin. The secondary end points, established in 1990, were all-cause mortality and total cancer mortality, total cancer incidence, and the incidences of lung, prostate, and colorectal cancers. After a total follow-up of 8271 person-years, selenium treatment did not significantly affect the incidence of basal cell or squamous cell skin cancer. There were 377 new cases of basal cell skin cancer among patients in the selenium group and 350 cases among the control group (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28), and 218 new squamous cell skin cancers in the selenium group and 190 cases among the controls (RR, 1.14; 95% CI, 0.93-1.39). Analysis of secondary end points revealed that, compared with controls, patients treated with selenium had a nonsignificant reduction in all-cause mortality (108 deaths in the selenium group and 129 deaths in the control group [RR; 0.83; 95% CI, 0.63-1.08]) and significant reductions in total cancer mortality (29 deaths in the selenium treatment group and 57 deaths in controls [RR, 0.50; 95% CI, 0.31-0.80]), total cancer incidence (77 cancers in the selenium group and 119 in controls [RR, 0.63; 95% CI, 0.47-0.85]), and incidences of lung, colorectal, and prostate cancers. Primarily because of the apparent reductions in total cancer mortality and total cancer incidence in the selenium group, the blinded phase of the trial was stopped early. No cases of selenium toxicity occurred. Selenium treatment did not protect against development of basal or squamous cell carcinomas of the skin. However, results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites. These effects of selenium require confirmation in an independent trial of appropriate design before new public health recommendations regarding selenium supplementation can be made