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Safety and Efficacy of Glucomannan for Weight Loss in Overweight and Moderately Obese Adults

Wiley
Journal of Obesity
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Abstract and Figures

Background: Few safe and effective dietary supplements are available to promote weight loss. We evaluated the safety and efficacy of glucomannan, a water-soluble fiber supplement, for achieving weight loss in overweight and moderately obese individuals consuming self-selected diets. Methods: Participants were randomly assigned to take 1.33 grams of glucomannan or identically looking placebo capsules with 236.6 mL (8 ounces) of water one hour before breakfast, lunch, and dinner for 8 weeks. The primary efficacy outcome was change in body weight after 8 weeks. Other efficacy outcomes were changes in body composition, hunger/fullness, and lipid and glucose concentrations. Safety outcomes included gastrointestinal symptoms/tolerance and serum liver enzymes and creatinine levels. Results: A total of 53 participants (18-65 years of age; BMI 25-35 kg/m²) were enrolled and randomized. The two groups did not differ with respect to baseline characteristics and compliance with the study supplement. At 8 weeks, there was no significant difference between the glucomannan and placebo groups in amount of weight loss (-.40 ± .06 and -.43 ± .07, resp.) or other efficacy outcomes or in any of the safety outcomes. Conclusions: Glucomannan supplements administered over 8 weeks were well tolerated but did not promote weight loss or significantly alter body composition, hunger/fullness, or lipid and glucose parameters. This trial is registered with NCT00613600.
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Hindawi Publishing Corporation
Journal of Obesity
Volume , Article ID , pages
http://dx.doi.org/.//
Clinical Study
Safety and Efficacy of Glucomannan for Weight Loss in
Overweight and Moderately Obese Adults
Joyce K. Keithley,1Barbara Swanson,1Susan L. Mikolaitis,2Mark DeMeo,3
Janice M. Zeller,4Lou Fogg,5and Jehan Adamji6
1RushUniversityCollegeofNursing,600S.PaulinaStreet,Suite1080,Chicago,IL60612,USA
2Rush University Medical Center, 1725 W. Harrison Street, Chicago, IL 60612, USA
3Section of Gastroenterology and Nutrition, Rush University Medical Center, 1725 W. Harrison Street, Chicago, IL 60612, USA
4NorthParkUniversitySchoolofNursing,3225W.FosterAvenue,Chicago,IL60625,USA
5Community,Systems,andMentalHealthNursing,RushUniversityCollegeofNursing,600S.PaulinaStreet,Suite1080,
Chicago, IL 60612, USA
6Faculty Practice, Rush University College of Nursing, 600 S. Paulina Street, Suite 1080, Chicago, IL 60612, USA
Correspondence should be addressed to Joyce K. Keithley; joyce kkeithley@rush.edu
Received  September ; Revised  December ; Accepted  December 
Academic Editor: Jordi Salas-Salvad´
o
Copyright ©  Joyce K. Keithley et al. is is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.
Background. Few safe and eective dietary supplements are available to promote weight loss. We evaluated the safety and ecacy
of glucomannan, a water-soluble ber supplement, for achieving weight loss in overweight and moderately obese individuals
consuming self-selected diets. Methods. Participants were randomly assigned to take . grams of glucomannan or identically
looking placebo capsules with . mL ( ounces) of water one hour before breakfast, lunch, and dinner for  weeks. e
primary ecacy outcome was change in body weight aer  weeks. Other ecacy outcomes were changes in body composition,
hunger/fullness, and lipid and glucose concentrations. Safety outcomes included gastrointestinal symptoms/tolerance and serum
liver enzymes and creatinine levels. Results. A total of  participants (– years of age; BMI – kg/m2)wereenrolledand
randomized. e two groups did not dier with respect to baseline characteristics and compliance with the study supplement. At 
weeks, there was no signicant dierence between the glucomannan and placebo groups in amount of weight loss (−.40 ± .06 and
−.43±.07, resp.) or other ecacy outcomes or in any of the safety outcomes. Conclusions. Glucomannan supplements administered
over  weeks were well tolerated but did not promote weight loss or signicantly alter body composition, hunger/fullness, or lipid
andglucoseparameters.istrialisregisteredwithNCT.
1. Introduction
Overweight and obesity are exceedingly dicult to reverse.
Despite the widespread use of conventional management
strategies—low-calorie diets, physical activity, behavioral
interventions, and pharmacological agents—the prevalence
of overweight and obesity continues to rise in the US.
An estimated % of all US adults were either overweight
or obese during - []. Overweight and obesity
increase the risk for comorbidities such as diabetes and
atherosclerosis and are associated with reduced quality of
life and life expectancy [,]. Clearly, alternative approaches
are needed. One potentially promising alternative approach
is glucomannan, a dietary supplement widely promoted and
used for its weight loss properties. Despite its widespread
use, the safety and ecacy of glucomannan have not been
adequately studied.
Glucomannan is a water-soluble, fermentable dietary
ber extracted from the tuber or root of the elephant yam,
alsoknownaskonjac(Amorphophallus konjac or Amor-
phophallus rivieri). Glucomannan consists of a polysaccha-
ride chain of beta-D-glucose and beta-D-mannose with
attached acetyl groups in a molar ratio of  : . with beta –
 linkages (see Figure )[]. Because human salivary and
Journal of Obesity
Glucose Glucose with Mannose Mannose
acetate group
on carbon 6
CH2OH CH2OH CH2OH
CH2OCOCH3
H
H
H
H
HH
H
HH
H
H
H
H
H
H
HH
H
H
O
OOO
O
O
OO
OH OH
OH HOOH
OH
H
OH HO
1
2
3
4
5
6
F : Structure of a segment of glucomannan with repeating glucose and mannose units.
pancreatic amylase cannot split beta ,  linkages, glucoman-
nan passes relatively unchanged into the colon, where it is
highly fermented by colonic bacteria. It has a high molecular
weight (average: ,, Daltons) and can absorb up to 
times its weight in water, making it one of the most viscous
dietary bers known []. erefore, glucomannan is taken in
smaller doses than other types of ber supplements.
e mechanisms that mediate the weight reduction
eects of glucomannan are thought to be similar to those
of other water-soluble, fermentable bers. With its low
energy density and bulking properties, glucomannan seems
to promote weight loss by displacing the energy of other
nutrients and producing satiety and satiation as it absorbs
water and expands in the gastrointestinal tract. In addition,
glucomannan seems to reduce total cholesterol and low-
density lipoprotein (LDL) cholesterol levels by stimulating
fecal excretion of cholesterol and bile acids and decreasing
intestinal absorption of cholesterol []. Also, glucomannan
may improve glycemic parameters by inhibiting appetite
and slowing intestinal absorption due to increased viscosity
[]. Glucomannan is generally well tolerated and has a
favorable safety prole.
Glucomannan has been associated with reductions in
body weight and plasma lipid and glucose levels in adults in a
few clinical trials []. But these trials have been limited by
weak designs, small sample sizes, heterogeneous diagnoses,
variable formulations and dosages of glucomannan, and short
duration of follow-up []. In contrast to these studies,
we used a randomized, double-blind, placebo-controlled
design to evaluate the safety and ecacy of . g/day of
glucomannan capsules in a sample of  healthy overweight
and moderately obese adults consuming self-selected diets
and maintaining usual physical activity levels during an -
week study period.
2. Materials and Methods
2.1. Study Population. Men and women were recruited from
a clinic within an urban academic medical center, located
in a Health Resources and Services Administration (HRSA)
designated medically underserved area. Individuals were
eligible for inclusion in the study if they were between the ages
of  and  years and had body mass index (BMI)  and
 at study entry. Individuals were not eligible if they were
currently using ber supplements or had intolerance to ber
supplements, had untreated/unstable metabolic conditions
knowntoinuenceweightstatus(e.g.,hypothyroidism,type
 diabetes mellitus), had gastrointestinal disorders that might
cause complications or inuence motility or satiety (e.g.,
diverticulitis, inammatory bowel disease, irritable bowel
syndrome, intestinal narrowing or obstruction, and di-
culty swallowing), were using medications or complementary
and alternative medicine (CAM) therapies that might aect
weight or food absorption (e.g., diuretics, glucocorticoids,
anorexigenic agents, Orlistat, acupuncture, and Hoodia), had
an eating disorder, or were participating in a weight loss
program. Other exclusion criteria were stage II hypertension
(/ mmHg) or dyslipidemia (fasting LDL cholesterol
 mg/dL; total cholesterol  mg/dL; triglycerides >
 mg/dL; HDL  mg/dL), fasting serum glucose >
 mg/dL, renal or liver disease, history of depression, abuse
of illicit drugs or alcohol, use of cigarettes, or pregnant, less
than  months postpartum, or lactating.
Based on a previous placebo-controlled trial of gluco-
mannan [], we planned to recruit  participants and follow
them up for  weeks to have % power to adequately detect
changes in weight and other metabolic variables.
2.2. Study Design. Eligible individuals who consented to par-
ticipate in the study were randomly assigned to receive cap-
sules containing glucomannan or a matching placebo lled
with inactive microcrystalline cellulose. A random number
generator was used to create a randomization sequence;
boxes containing each participant’s supply of capsules were
packaged according to this sequence. Both the glucomannan
and placebo capsules were prepared by an external pharmacy,
whichhadnootherroleinthestudy.Toensurethatthe
glucomannan supplement used during the study period met
quality control standards, it was purchased from the same
lot, and a sample was submitted to ConsumerLab.com for
compositional and purity analyses, which indicated appropri-
ate composition and purity. Neither the participants nor the
investigators were aware of the treatment assignments.
Participants were instructed to take two  mg (. g)
glucomannan or placebo capsules with . mL ( oz.) of
water one hour before breakfast, lunch, and dinner for 
weeks (for a total of . g/day). ey were also encouraged
to maintain their current dietary intake and physical activity
Journal of Obesity
levels. Study participants returned at  weeks and  weeks
to return any unused study supplement or placebo from the
previous visit, receive a new supply of the study supplement
or placebo for the remaining  weeks, report on side eects,
andhaveblooddrawn.
Alldatawerecollectedbystudyresearchpersonneland
uploaded to TeleForm (electronic scanning) database by
aresearchassistant.estudywasapprovedbythesite
institutional review board. All participants provided written
informed consent before enrollment. An independent data
and safety monitoring committee monitored the trial and
reviewed the interim results.
2.3. Primary Outcome. e primary ecacy outcome was
weight loss from baseline to  weeks and  weeks aer
randomization. Body weight was measured to the nearest
/ kg using a calibrated electronic scale, with participants
wearing light clothing without shoes [].
2.4. Secondary Outcomes. Secondary ecacy outcomes in-
cluded changes in body composition (waist/hip circumfer-
ence, body fat, and fat-free mass), hunger and fullness, and
fasting lipids and blood glucose parameters. Waist and hip
circumference were determined using standardized proce-
dures [] and body fat and fat-free mass were measured
using Tanita Ultimate Scale (Tanita Corp., Tokyo, Japan).
Subjective sensations of hunger and fullness were assessed
using standardized mm visual analog scales (VAS) [].
e hunger scale was anchored by the words, “Not at all
hungry” and “Extremely hungry” and the fullness scale was
anchored by “Not at all full” and “Extremely full.” Participants
wereaskedtomakeaverticalmarkacrossthelinecorre-
sponding to their feelings during the past four hours on the
day of their scheduled clinic visit (total = three days during
the-weekstudyperiod).Toscorethescales,thedistance
in mm from  for each scale was measured with a ruler.
Fasting peripheral venous blood specimens were obtained for
glucoseandlipidlevels.Astandardlipidpanelwasusedto
quantify triglycerides, total cholesterol, and HDL cholesterol;
LDL cholesterol levels were calculated using the Friedewald
equation.
Key safety outcomes were gastrointestinal symptoms and
tolerability and laboratory assessment of liver and renal
function. Gastrointestinal symptoms and tolerance were
determined by asking participants about diculty swallow-
ing, abdominal distention, diarrhea, belching, and other
gastrointestinal-related symptoms using standard methods of
nondirected questioning, including when symptoms started
and whether they were thought to be related to the study
supplement. Liver enzymes were considered elevated with an
aspartate aminotransferase level > u/L and/or an alanine
transferase> u/L; for serum creatinine, a level >. mg/dL
was considered elevated.
Other measures included dietary intake, physical activity,
supplement compliance, and credibility/expectancy percep-
tions of the study treatment. To assess for changes over the
-week study period, dietary intake was measured using
-day food records completed at baseline,  weeks, and 
weeks and analyzed using NutriBase clinical data analy-
sis soware (http://www.nutribase.com/). e International
Physical Activity Questionnaire (IPAQ) []wasadminis-
tered at baseline,  weeks and  weeks to characterize any
changes in usual activity level during the study period that
could aect study outcomes. Supplement compliance was
measured by capsule counts and self-report of percentage
of capsules taken. Calculated compliance was dened as the
percentage of prescribed doses taken from baseline through
the -week study period. Since dierences in participants
perceptions of credibility of the treatment rationale and their
expectancy could confound the ndings, we administered the
credibility/expectancy Questionnaire (CEQ) to participants
in both groups on the rst and last days of the treatment [].
2.5. Statistical Analysis. All statistical analyses were per-
formed with SPSS . (Chicago, IL). Descriptive statistics
were used to characterize the sample. Nominal data were
analyzed by the use of the chi-square test, whereas contin-
uous data were analyzed by the use of Pearson’s correlation
analyses, independent sample 𝑡-tests, and one-way analysis of
variance.edataarepresentedasmean±SD. A signicance
level of . was determined apriori.
3. Results
3.1. Study Population. Figure  depicts the screening, enroll-
ment, and follow-up of participants in the trial. Of the 
adults screened, a total of  met eligibility criteria and
were enrolled in the study. Twenty-six participants were
randomly assigned to the glucomannan group and twenty-
sevenparticipantstotheplacebogroup.erewereno
signicant dierences between the two groups in rates of
discontinuation. ree participants in each group were either
lost to follow-up or discontinued the study for personal
reasons, resulting in a nal sample of  participants.
Baseline demographic and clinical characteristics were
similar between the two groups (Tab l e  ). Participants were
predominately female (%), represented a mix of racial
andethnicgroups,andhadameanageof.years.For
the  participants who completed the study, the calculated
compliance was .% ±.% in the glucomannan group and
.% ±% in the placebo group.
3.2. Study Outcomes. For the primary outcome, there was no
signicant dierence in the amount of weight loss between
the participants in the glucomannan group and those in the
placebo group at either two weeks (. ±. and . ±
., resp.) or eight weeks (. ±. and . ±., resp.)
aer randomization (Tabl e  ). Results of secondary ecacy
outcomes are also shown in Table . ere were no signicant
dierences in body composition measures, hunger/fullness,
andfastinglipidandglucoselevels.Belching(.%versus
.%), bloating (.% versus .%), and stomach fullness
(.% versus .%) occurred more frequently in partici-
pants on glucomannan than those on placebo, but these
symptoms were transient, lasting for only - hours aer
taking glucomannan on the rst – study days, and did
Journal of Obesity
53 eligible and randomized
124 screened for eligibility
26 randomized to intervention 27 randomized to placebo
23 completed study 24 completed study
23 included in analysis 24 included in analysis
study (n=2, personal reasons) study (n=1, personal reasons)
lost to follow-up (n=2); discontinuedlost to follow-up (n=1); discontinued
F : Study ow diagram.
T : Baseline demographic and clinical characteristics of study participants (𝑁 = 47).
Characteristic: 𝑛(%) Glucomannan (𝑛 = 23) Control (𝑛 = 24)
Gender
Male  (%)  (.%)
Female  (%)  (.%)
Race/ethnic group
White  (.%)  (.%)
Black  (.%)  (.%)
Hispanic  (.%)  (.%)
Other  (.%)  (%)
Characteristic: mean (±SD)
Age, years . (.) . (.)
Height, /in . (.) . (.)
Weight, kg . (.) . (.)
Body mass index, kg/m. (.) . (.)
Waist circumference, cm . (.) . (.)
Hip circumference, cm . (.) . (.)
Fat mass, kg . (.) . (.)
Fat-free mass, kg . (.) . (.)
Total cholesterol, mg/dL . (.) . (.)
LDL cholesterol, mg/dL . (.) . (.)
HDL cholesterol, mg/dL . (.) . (.)
Triglycerides, mg/dL . (.) . (.)
Fasting glucose, mg/dL . (.) . (.)
not lead to study discontinuation. Hepatic and renal safety
outcomes remained normal throughout the study and did not
signicantly dier between the control and treatment groups.
Other measures, including dietary intake, physical activity,
supplement compliance, and credibility/expectancy, also did
not dier signicantly between the groups.
4. Discussion
In our study, supplementation with glucomannan did not
result in signicant weight loss at either  or  weeks aer
randomization. Also, there was no evidence of benet of
glucomannan supplementation with respect to any of the
Journal of Obesity
T : Eects of glucomannan on ecacy outcomes (𝑁 = 47).
Characteristic: mean Glucomannan (𝑛 = 23) Control (𝑛 = 24)
Baseline  weeks  weeks Baseline  weeks  weeks
Weight, kg . . . . . .
Weight loss, kg . . — . .
BMI, kg/m. . . . . .
Waist circum., cm . . . . . .
Hip circum., cm . . . . . .
Fat mass, kg . . . . . .
Fat-free mass, kg . . . . . .
Hunger, mm . . . . . .
Fullness, mm . . . . . .
Cholesterol, mg/dL . . . . . .
HDL, mg/dL . . . . . .
LDL, mg/dL . . . . . .
Triglycerides, mg/dL . . . . . .
Glucose, mg/dL . . . . . .
secondary outcomes. is is in contrast to several other
studies that have found benecial eects of glucomannan on
body weight, body composition, and plasma lipid and glucose
levels [,].
Several factors may explain our study’s nonsignicant
ndings. Unlike previous studies, we enrolled only healthy
overweight and moderately obese individuals consuming
self-selected diets and maintaining usual physical activity
levels.AsnotedbySoodetal.[], the benecial eects of
glucomannan on weight loss may be enhanced by dietary
modications, such as hypocaloric diets. Additionally, past
studies have focused on obese patients, so it is possible
that glucomannan may exert dierential eects on these
individuals compared to the overweight or moderately obese
(mean BMI = ) participants in the present study.
e lack of body composition changes may be due to the
absenceofanexerciseinterventionaspartofthestudydesign.
Other trials suggest that glucomannan in conjunction with
resistance and endurance exercise is necessary to promote
changes in body composition, including waist and hip cir-
cumference, fat mass, and fat-free mass [].
We also found no changes in plasma lipid or glucose
concentrations. A possible explanation is that we enrolled
only healthy individuals and excluded those with dyslipi-
demia or elevated serum glucose. us, oor eects may
have precluded detecting any eects of glucomannan on
these parameters. Another possible explanation is the lack of
weight loss in our sample and its eects on these parameters
[].
Irregular eating patterns also may provide an explanation
for our results. Rather than eating  meals, many partici-
pants reported that they “grazed” throughout the day and
ate the majority of their calories in the evening, possibly
circumventing our dosing schedule of  capsules one hour
before breakfast, lunch, and dinner. Similarly, irregular eating
patterns may explain the lack of dierence in hunger and
fullness sensations between the two groups. To eectively
coordinate dosing and eating schedules, a more tailored or
individualized approach should be considered.
While the dosage (. g/day) of glucomannan used in
our study was similar to or at the lower range of those used
in other studies, a higher dosage of glucomannan should be
tested in future studies. Of special interest would be whether
higher doses of glucomannan might be more eective in this
population. Ten grams of soluble ber per day is considered
the maximum practical dose [].
ree limitations of this trial should be considered. First,
our nal sample size (𝑛=47) was relatively modest. Given
the type II error that can occur with small sample sizes, this
might be a possible explanation for lack of treatment eects.
Second, the moderate duration of our study did not permit
either long-term safety or ecacy evaluation. Glucomannan
was generally well tolerated and liver enzymes and serum
creatinine levels remained favorable during the -week study
period; however, few studies have examined the long-term
safety of glucomannan, and this should be a focus of future
trials since extended use may impact intestinal absorption of
key nutrients, particularly fat-soluble vitamins, carotenoids,
and phytosterols. Similarly, glucomannan may be more ben-
ecial over the long term when used with healthy overweight
and moderately obese individuals. ird, we relied on self-
report and capsule counts to monitor compliance. While
participants in both groups reported a slightly greater than
% compliance rate, it is possible that physiologic measures
of compliance such as end product metabolites of glucoman-
nan coupled with the use of electronic capsule monitoring
systems would have resulted in more precise measures of
compliance. In addition to phone and e-mail reminders, other
technological measures to improve compliance such as text
message reminders and tweets would be of interest in future
studies.
Journal of Obesity
5. Conclusions
In summary, glucomannan supplements (. g daily) were
well tolerated but did not promote weight loss in overweight
and moderately obese individuals consuming self-selected
diets and maintaining usual physical activity patterns. Other
outcomes such as body composition, hunger/fullness, and
lipid and glucose parameters also were not signicantly
altered. ese results are inconsistent with the results of
previous studies. Given the growing epidemic of obesity,
additional studies to assess the safety and ecacy of this
widely used alternative weight loss approach are needed.
Future trials should evaluate glucomannan using larger
numbers of participants, longer study follow-up periods,
exible dosing schedules, and higher dosages and should
continue to include diverse populations of overweight and
obese individuals.
Acknowledgment
is study was funded by the Roberts Trust Fund, Chicago,
IL.
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Konjac mannan consumed 0.991 moles of sodium metaperiodate per anhydrohexose residue. The Smith degradation of this glucomannan produced large amounts of glycolaldehyde and erythritol, in addition to small amounts of d-mannose, d-glucose and glycerol. Complete acid-hydrolysis of the glucomannan yielded d-mannose and d-glucose in a molar ratio of 1.6:1.00 or 8:5. The hydrolysate of konjac glucomannan by β-mannanase preparation from konjac tubers yielded a mixture of oligosaccharide, from which the following compounds were isolated and identified: (1) M→M, (2) G→M, (3) G→G, (4) M→M→M, (5) G→M→M, (6) M→G→M, (7) G→G→M, (8) M→M→M→M, (9) G→M→M→M, (10) G→M→M→G, (11) G→G→M→M, (12) M→M→M→M→M, (13) G→M→M→M→M. On the basis of the above results, the possible structures of this glucomannan and the specificities of β-mannanase were discussed.
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About 97 million adults in the United States are overweight or obese. Obesity and overweight substantially increase the risk of morbidity from hypertension; dyslipidemia; type 2 diabetes; coronary heart disease; stroke; gallbladder disease; osteoarthritis; sleep apnea and respiratory problems; and endometrial, breast, prostate, and colon cancers. Higher body weights are also associated with increases in all-cause mortality. The aim of this guideline is to provide useful advice on how to achieve weight reduction and maintenance of a lower body weight. It is also important to note that prevention of further weight gain can be a goal for some patients. Obesity is a chronic disease, and both the patient and the practitioner need to understand that successful treatment requires a life-long effort. Assessment of Weight and Body Fat Two measures important for assessing overweight and total body fat content are; determining body mass index (BMI) and measuring waist circumference. 1. Body Mass Index: The BMI, which describes relative weight for height, is significantly correlated with total body fat content. The BMI should be used to assess overweight and obesity and to monitor changes in body weight. Measurements of body weight alone can be used to determine efficacy of weight loss therapy. BMI is calculated as weight (kg)/height squared (m 2). To estimate BMI using pounds and inches, use: [weight (pounds)/height (inches) 2 ] x 703. Weight classifications by BMI, selected for use in this report, are shown in the table below. • Pregnant women who, on the basis of their pre-pregnant weight, would be classified as obese may encounter certain obstetrical risks. However, the inappropriateness of weight reduction during pregnancy is well recognized (Thomas, 1995). Hence, this guideline specifically excludes pregnant women. Source (adapted from): Preventing and Managing the Global Epidemic of Obesity. Report of the World Health Organization Consultation of Obesity. WHO, Geneva, June 1997.
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The present study is the first to report the hypocholesterolemic effect of chitosan on humans. When 3–6 g/day of chitosan was given in the diet to 8 healthy males, total serum cholesterol significantly decreased, and when the ingestion was stopped, the value increased to the level before ingestion. Serum HDL-cholesterol was increased significantly by the ingestion of chitosan. The excreted amounts of primary bile acids, cholic acid and chenodeoxycholic acid, into the feces was significantly increased by the ingestion of chitosan, and the amount of cholic acid excretion decreased significantly after the ingestion was stopped. These facts suggest that chitosan combined bile acids in the digestive tract, and that the combined product was excreted into the feces. This, in turn, deceased the resorption of bile acids, so that the cholesterol poool in the body was decreased and the level of serum chrolesterol consequently decreased.