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Int. J. Environ. Res. Public Health 2021, 18, 6257. https://doi.org/10.3390/ijerph18126257 www.mdpi.com/journal/ijerph
Article
Reduced Self-Perception of Fatigue after Intake of
Panax ginseng Root Extract (G115
®
) Formulated with
Vitamins and Minerals—An Open-Label Study
Anne-Laure Tardy
1,
*, Beatrice Bois De Fer
1
, Salvador Cañigueral
2
, David Kennedy
3
, Andrew Scholey
4
,
Simon Hitier
1
, Alexia Aran
1
and Etienne Pouteau
1
1
Sanofi Global Consumer Health Care, 94250 Gentilly, France; Beatrice.Bois-de-Fer@sanofi.com (B.B.D.F.);
Simon.Hitier@sanofi.com (S.H.); alexia.aran@sanofi.com (A.A.); Etienne.Pouteau@sanofi.com (E.P.)
2
Unit of Pharmacology, Pharmacognosy and Therapeutics, Faculty of Pharmacy and Food Sciences,
University of Barcelona, 08007 Barcelona, Spain; s.canigueral@ub.edu
3
Brain, Performance and Nutrition Research Centre, Faculty of Health and Life Sciences,
Northumbria University, Newcastle-upon-Tyne NE1 8ST, UK; david.kennedy@northumbria.ac.uk
4
Centre for Human Psychopharmacology, Swinburne University, Melbourne, VIC 3122, Australia;
andrew@scholeylab.com
* Correspondence: Anne-Laure.Tardy@sanofi.com; Tel.: +33-6-7023-2263
Abstract: Background: Unexplained fatigue is a common complaint. When underlying disease
causes have been eliminated, lifestyle measures and supplementation can be indicated. Elaborating
on clinical findings that G115
®
, a dry extract from the root of Panax ginseng, combined with vitamins
and minerals could alleviate fatigue, this open label study aimed at assessing its effect on perceived
fatigue and energy. Methods: Healthy adults self-reporting fatigue (n = 103) completed the Multi-
dimensional Fatigue Inventory questionnaire. They rated their perceptions of mental and physical
fatigue, energy, performance, and stress at baseline and 15, 30, 60 and 90 days after a daily intake
of 40 mg G115
®
formulated with vitamins and minerals. Results: Compared with baseline values,
mean self-perception of general fatigue was reduced by −7.55 units [95% CI: −8.44; −6.66] (−41.8%, p
< 0.0001) at 90 days. All assessed perception ratings (mental and physical fatigue, reduced activity
and motivation, performance, and stress) were significantly and steadily improved from two weeks
after supplementation up to study’s end. Overall satisfaction with the ability of the product to re-
duce fatigue reached 85% at Day 90. Conclusion: Daily intake with G115
®
extract formulated with
vitamins and minerals suggests an improvement of self-perception of fatigue and energy in a fa-
tigued adult population.
Keywords: Panax ginseng G115
®
, fatigue; energy; vitamins; minerals
1. Introduction
The concept of energy, in everyday language, is associated with the feelings of vital-
ity and well-being that make our daily physical or intellectual activities possible. Con-
versely, fatigue is usually described as a perceived lack of energy [1]. Energy and fatigue
are thus interrelated opposite perceptions, each characterized by physical and mental
components. In healthy individuals, the main causes of fatigue and lack of energy are
related to professional occupation, factors related to domestic and social events, and indi-
vidual lifestyle or behavior [2,3]. Beyond perceptions and feelings, fatigue and lack of en-
ergy also result in decreased physical, cognitive and psychological performance [4]. Rec-
ommendations and the means to alleviate fatigue and its consequences are frequently re-
quested by physicians [5], who usually promote a healthy lifestyle, including a balanced
diet and sufficient sleep, having eliminated any underlying, disease-associated cause [6].
Citation: Tardy, A.-L.; Bois De Fer,
B.; Cañigueral, S.; Kennedy, D.;
Scholey, A.; Hitier, S.; Aran, A.;
Pouteau, E. Reduced Self-Perception
of Fatigue after Intake of
Panax ginseng Root Extract (G115
®
)
Formulated with Vitamins and
Minerals—An Open-Label Study.
Int. J. Environ. Res. Public Health 2021,
18, 6257. https://doi.org/10.3390/
ijerph18126257
Academic Editor: Dagrun Engeset
Received: 2 March 2021
Accepted: 8 June 2021
Published: 9 June 2021
Publisher’s Note: MDPI stays neu-
tral with regard to jurisdictional
claims in published maps and insti-
tutional affiliations.
Copyright: © 2021 by the authors. Li-
censee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and con-
ditions of the Creative Commons At-
tribution (CC BY) license (http://crea-
tivecommons.org/licenses/by/4.0/).
Int. J. Environ. Res. Public Health 2021, 18, 6257 2 of 10
Alleviation of fatigue and the maintenance of general health have been reported as the
most common motivations for taking supplements [7].
Vitamins and minerals are of key importance for their contribution to normal energy-
yielding metabolism in the body. They are essential for various metabolic reactions that
enable the transformation of carbohydrates, lipids, and proteins from food into chemical
energy. In addition to this energy-yielding function, vitamins and minerals have critical
functions in pathways that support the synthesis of nucleic acids, the transport of oxygen,
and neuronal function, thereby impacting on muscular, cognitive and psychological func-
tion, as well as on mental and physical fatigue [4,8]. Several observational studies have
reported that fatigue and poorer functioning are associated with lower status in some mi-
cronutrients, such as iron [9] or vitamin C [10].
The root of Panax ginseng C.A. Meyer, also known as Asian or Korean ginseng, has
been used for centuries in Chinese and other traditional Asian medicines, for a wide vari-
ety of ailments, including, but not restricted to, general weakness, lack of appetite, and
anxiety. Possible underlying mechanisms include antioxidant properties, regulation of
carbohydrate metabolism, promotion of the mitochondrial function, neuroprotection and
the prevention of neurotransmitter disorders in the central nervous system, according to
a recent systematic review [11]. It has been used in the Western world since the end of the
19
th
century, as a traditional medicine indicated in cases of tiredness, weakness and de-
creased mental and physical capacity [12–14].The roots of Panax ginseng are authorized as
a herbal extract for use within food supplements in many countries, such as in France [15],
Belgium, [16] or Italy [17]. A specific extract referred to as G115
®
, standardized to contain
4% of ginsenosides, considered the active components of the herbal drug was first inves-
tigated in the early 1980s. In addition to preclinical studies in animals or in vitro, aimed
at identifying potential mechanisms of action of Panax ginseng [18], clinical studies have
documented the physiological effects of G115
®
over the last 40 years [19,20]. When focus-
ing only on the clinical trials that address cognition, fatigue, or well-being outcomes, more
than 20 studies have been undertaken up to now, most of them double blinded and pla-
cebo-controlled trials using G115
®
alone or in combination with vitamins and minerals.
Indeed, G115
®
was demonstrated to help maintain mental performance, especially in case
of fatigue and highly demanding tasks [21–26]. In addition, the combination of G115
®
ex-
tract with vitamins and minerals was able to improve the quality of life in subjects expe-
riencing high levels of physical and mental stress [27] or presenting an overall low quality
of life [28]. This formulation also helped to reduce memory deficits and self-reported fa-
tigue in shift-workers [29]. Thus, there is a consistent effect of Panax Ginseng G115
®
ex-
tract, alone or in combination with vitamins and minerals, on memory, and especially on
secondary memory, a key component of working memory. In addition, most studies con-
clude to an improvement in well-being and the quality of life and a reduction in perceived
mental fatigue, which is particularly visible when subjects are in a challenging situation,
such as for shift-workers, people with enhanced stress or poor quality of life at baseline,
or when challenged by a demanding cognitive task.
Given the relationship between micronutrient status and fatigue, and the described
effects of the root of Panax ginseng, a study investigating a marketed food supplement
containing 11 vitamins, 6 minerals and G115
®
Panax ginseng extract was set up in healthy,
non-elderly adult participants reporting a subjective fatigue. The primary objective was
to evaluate the self-perception of general fatigue after 3 months of daily intake with the
combination of vitamins, minerals and G115
®
Panax ginseng extract, and the secondary
objectives were to evaluate the self-perception of physical fatigue, mental fatigue, reduced
activity, motivation, and stress, and assess the satisfaction with the product usage. All
these perceptions were evaluated at regular intervals during a 3-month period, in order
to provide insights to the kinetics of expected changes.
Int. J. Environ. Res. Public Health 2021, 18, 6257 3 of 10
2. Material and Methods
2.1. Ethics
This study was conducted from December 2018 to March 2019 in two centers in Spain
(Madrid and Valencia), as a behavioral study test in healthy volunteers with a marketed
food supplement and without invasive methods of evaluation. The study is compliant
with the International Code on Market, Opinion and Social Research and Data Analytics
[30]. It was approved by the Parc Taulí’s CEIm Ethics committee in Barcelona, which con-
siders that the necessary requirements for the appropriateness of the protocol in relation
to the objectives of the study are met and the foreseeable risks and discomfort to the sub-
ject are justified. All participants provided written informed consent prior to participation
and received financial compensation.
2.2. Study Participants
Male and female subjects in good overall health and aged 18 to 45 were included if
they declared a lack of energy and vitality, and persistent fatigue for at least two weeks.
Inclusion was also dependent on the subject presenting a score ≥10 on the dimension of
general fatigue of the Multidimensional Fatigue Inventory (MFI) and a score ≥3 for at least
ten of the 20 questions of the MFI [31]. Subjects were excluded if they were working at
night, taking any food supplements in the month before study onset, or if their usual daily
intakes exceeded four cups of coffee, two glasses of alcohol, or five cigarettes. Weekly
intakes exceeding three energy drinks or five snacks and performing more than 45-min
medium to intense physical exercise more than twice weekly were also exclusion criteria.
A total of 130 subjects were screened, of whom 105 subjects were included. Baseline
characteristics are described in Table 1, including scores on the MFI before the study
started.
Table 1. Baseline characteristics of subjects (n = 103).
Demographic Characteristics
Age (years; mean ± SD) 35.1 ± 7.87
Gender (% male) 25.2
Professional activity
Full time remunerated (%) 62.1
Part time remunerated; others (%) 24.3
Students 13.6
Lifestyle Characteristics
Smoking habits (% non-smokers) 98.1
Alcohol habits (% with no intake) 81.6
Energy drinks consumption (% non-consumers) 92.2
Snack intake (% consumers once or more weekly) 50.5
Physical Activity (% with no medium or enhanced weekly sporting activities)
89.3
MFI-20 Subscale Scores (arbitrary units, mean ± SD)
General fatigue 17.9 ± 2.04
Physical fatigue 16.7 ± 2.57
Mental fatigue 14.6 ± 1.71
Reduced activity 14.1 ± 4.16
Reduced motivation 13.5 ± 3.36
Numerical Rating Scores (11-point scale)
Fatigue 8.1 ± 1.76
Mental & physical performance 3.8 ± 2.60
Stress 6.3 ± 2.52
MFI, Multidimensional Fatigue Inventory; SD, standard deviation.
Int. J. Environ. Res. Public Health 2021, 18, 6257 4 of 10
2.3. Study Product
The supplement consists in soft gelatin capsules, each containing 1.1 mg vitamin B1,
1.4 mg vitamin B2, 16 mg vitamin B3, 1.4 mg vitamin B6, 50 µg vitamin B8, 200 µg vitamin
B9 (folate), 2.5 µg vitamin B12, 800 µg vitamin A, 60 mg vitamin C; 5 µg vitamin D, 12 mg
vitamin E, 1 mg copper, 10.5 mg iron, 2 mg manganese, 55 µg selenium, 1.5 mg zinc and
120 mg calcium. The recommended daily dose is one capsule which delivers amounts
within the order of magnitude of the recommended daily dose for an adult for each vita-
min and mineral described. In addition, each capsule contains 40 mg of G115
®
, which is a
dry extract obtained from the root of Panax ginseng (C.A. Meyer) (drug-extract ratio 3–7:1),
using ethanol 40% v/v as extraction solvent. G115
®
is standardized to 4% of ginsenosides
(sum of ginsenosides Re, Rf, Rg1, Rg2, Rb1, Rb2, Rc and Rd) by the addition of excipients
(43–68% lactose, and 2% silicon dioxide). Quality assurance for all the manufacturing
steps, standardization and quality control of the process guarantees the same batch-to-
batch content and composition of ginsenosides, which is the basis for reproducibility of
the safety and efficacy of the final product [32].
2.4. Study Procedure
Participants were asked to consume one capsule each morning for 90 days, and to
evaluate their self-perception of fatigue using MFI and of stress using Numerical Rating
Scales (NRS), as well as their overall satisfaction with the product, in the evening (before
dinner) at baseline and after 1, 15, 30, 60, and 90 days of supplementation. In addition, on
the same days, at 3 time points during the day (30 min before lunch/in the afternoon/30
min before dinner) subjects were asked to rate their fatigue level, and mental and physical
performance using NRS. Sleep quality on the previous night (duration and variation from
habitual duration) was assessed in the evening (before dinner) after 30, 60, and 90 days of
supplementation.
Compliance was assessed via a specific questionnaire, which was completed by each
participant on a daily basis. Subjects came to the study centers for the inclusion visit and
baseline day, and questionnaires on any other day were completed at home. Compliance
was high during the study, except for two major protocol violations: one subject stopped
taking the supplement temporarily between D30 and D60 and one took the capsules at
another time than morning.
2.5. Study Endpoints
The MFI includes 20 items that are each rated on a 5-point scale. From these 20 items
are derived 5 subscales scores (expressed in arbitrary units (a.u.)) in the following do-
mains: general fatigue, physical fatigue, mental fatigue, activity reduction and motivation
reduction; higher scores indicate greater fatigue. The MFI questionnaire has been vali-
dated, both in English and Spanish languages [31,33] by successfully assessing, in differ-
ent groups of population, internal consistency and convergent validity [31].
The primary efficacy variable was the general fatigue subscale score after 90 days of
supplementation.
The secondary efficacy variables included the general fatigue subscale score after 1,
15, 30, and 60 days and the MFI subscale scores for physical fatigue, mental fatigue, re-
duced activity, and reduced motivation after 1, 15, 30, 60, and 90 days of supplementation.
Other secondary criteria were assessed using Numerical Rating Scales (NRS), which are
non-specific tools for the evaluation of fatigue and performance, but are nonetheless val-
idated in other areas, such as pain [34]. NRS for fatigue, stress, mental, and physical per-
formance at the same timepoints were additional secondary endpoints, as were the per-
centages of product satisfaction for each domain. NRS were on an 11-point scale. Subject
satisfaction was measured using a 4-category rate questionnaire from not satisfied at all
(score 1) to entirely satisfied (score 4) for physical fatigue, intellectual fatigue, stress level,
and overall satisfaction domains.
Int. J. Environ. Res. Public Health 2021, 18, 6257 5 of 10
2.6. Statistical Considerations
The sample size was calculated for the primary endpoint MFI-general fatigue at 90
days. A total of 73 subjects was needed to show a difference of 2.0 a.u., considered as the
minimal clinically important difference [35], associated with a standard deviation of 6.0
a.u. for the primary endpoint, using a two-sided comparison with a type 1 error rate con-
trolled at 5% and a power of 80%. The primary endpoint analysis was performed on the
per-protocol population, defined as all included subjects who presented no major protocol
deviation (n = 103). The primary analysis was the comparison of MFI at baseline vs. 90
days, using a mixed model for repeated measurements (MMRM), including time points
(baseline, D1, D15, D30, D60, D90) as categorical effects and subject as a random effect. A
Dunnett adjustment was performed for comparison between baseline and the other time
points for controlling the type 1 error rate. For NRS, the same MMRM was used but in-
cluding in addition the time of day (before lunch, afternoon, evening) and the interactions
between time points and time of day. The same adjustment as for MFI for comparison of
the other time point was used. MFI and NRS assessments were analyzed using a 5% 2-
sided significance level. No formal statistical comparison was planned for satisfaction
endpoints.
3. Results
3.1. Fatigue-Related and Energy-Related Outcomes
3.1.1. MFI Scores
General fatigue subscale score, the primary study endpoint, was decreased by 7.55
points [95% CI −8.44; −6.66] (41.8%), compared with baseline (p < 0.0001) after 3 months of
supplementation. During the same period, subscale scores for reported physical and men-
tal fatigue decreased by 6.10 points [95% CI −6.95; −5.25] (35.8%) and 3.91 points [95%CI
−4.45; −3.38] (26.1%), respectively. All the components of the MFI showed a significant
decrease from D15 up to D90 following the first intake of the study product (Table 2).
Table 2. Mean differences (expressed in arbitrary units) between baseline and post baseline visit of MFI subscale scores
and numerical rating scores for fatigue, performance, and stress at different times of supplementation with a vitamin and
mineral supplement containing Panax ginseng extract (G115
®
) (n = 103).
D1 D15 D30 D60 D90
MFI-20 subscale scores
General fatigue
−0.51 [−1.40; 1.39]
−3.97 [−4.86;−3.08] **
−5.64 [−6.53;−4.75] **
−6.97 [−7.86;−6.08] **
−7.55 [−8.44;−6.66] **
Physical fatigue −0.21 [−0.64; 1.06] −2.40 [−3.25;−1.55] ** −3.70 [−4.55;−2.85] ** −4.93 [−5.78;−4.08] ** −6.10 [−6.95;−5.25] **
Mental fatigue −0.44 [−0.97; 0.10] −2.09 [−2.62; −1.55] **
−2.93 [−3.47; −2.40] **
−3.53 [−4.07; −3.00] **
−3.91 [−4.45; −3.38] **
Reduced activity −0.52 [−1.42; 0.37] −2.29 [−3.18; −1.40] **
−3.73 [−4.62; −2.84] **
−4.75 [−5.64; −3.85] **
−5.44 [−6.33; −4.54] **
Reduced motivation −0.32[−1.09; 0.45] −2.82[−3.58; −2.05] ** −3.74 [−4.51; −2.97] **
−4.68 [−5.45; −3.91] **
−5.72 [−6.49; −4.95] **
Assessments by NRS
Fatigue −0.84 [−1.43; −0.26] * −2.20 [−2.79; −1.62] **
−2.66 [−3.25; −2.07] **
−3.04 [−3.63; −2.45] * −2.94 [−3.53; −2.35] **
Mental & physical performance
0.58 [−0.05; 1.22] 1.45 [0.81; 2.08] ** 2.16 [1.52; 2.79] ** 2.20 [1.57; 2.84] ** 2.21 [1.58; 2.85] **
Stress
−0.58 [−1.20; 0.04]
−1.62 [−2.24; −1.00] **
−1.93 [−2.55; −1.31] **
−2.48 [−3.10; −1.85] **
−2.30 [−2.92; −1.68] **
Least squares mean difference [95% confidence interval]: *: p = 0.0015; **: p < 0.0001. All NRS values are those reported in
the evening. D—day; MFI—Multidimensional Fatigue Inventory; NRS—Numerical Rating Scores.
3.1.2. Self-Evaluation of Fatigue and Performance via Numerical Rating Scales
The self-estimated fatigue level recorded in the evening was significantly decreased,
by 2.94 points [95% CI −3.53; −2.35] and the self-rated level of mental and physical perfor-
mance was significantly increased, by 2.21 points [95% CI −1.58; −2.85] after a 3-month
intake of the supplement. Statistically significant improvements were observed from 2
weeks after the initiation of the supplementation for all the assessed outcomes (Table 2).
Fatigue and performance ratings before lunch and in the afternoon displayed the same
trends, with significant favorable changes observed as soon as 2 weeks after the initiation
Int. J. Environ. Res. Public Health 2021, 18, 6257 6 of 10
of supplementation, which were sustained and strengthened up to 3 months (data not
shown). Improvements were thus noticeable and consistent throughout the whole day.
3.1.3. Satisfaction and Perceived Energy Scores
Regarding satisfaction with perceived physical and mental fatigue (Figure 1), there
was a clear trend towards a decreased number of non-satisfied participants over time.
Overall, 68% of subjects were unsatisfied when they started supplementation and this
percentage dropped down to 17% after 90 days (data not shown). More precisely, after 3
months 83% of individuals were satisfied with the decrease of physical fatigue and 82%
were satisfied regarding the decrease of mental fatigue, whereas only 32% had been sat-
isfied at study onset.
Figure 1. Percentage of population self-reporting the indicated level of satisfaction regarding the
ability of the product to reduce physical fatigue (A) and mental fatigue (B), from D1 to D90 follow-
ing supplementation. D—day.
When the nature and extent of the feelings of energy were investigated among the
subjects, very clear improvements were seen in terms of satisfaction, which steadily in-
creased during the study (Figure 2). Only 7% of subjects agreed they had a “feeling of
energy” at study onset, while 73% agreed with this statement after 3 months. Similarly,
between the start and end of the study, subjects agreement that they were “feeling at their
best level of energy during the whole day” increased from 9% up to 76% and positive
responses to the question of whether they were feeling “the right level of energy” in-
creased from 12% up to 65%. Most subjects (67%) agreed that their “energy level [was]
balanced throughout the day” after 3 months of supplementation, vs. a minority of sub-
jects (9%) at study onset. In addition (data not shown), 65% of individuals reported that
they were ‘more focused on daily challenges’ after 3 months, in comparison with 34% after
2 weeks, 49% after 1 month and 54% after 2 months.
Int. J. Environ. Res. Public Health 2021, 18, 6257 7 of 10
Figure 2. Percentage of population self-reporting the indicated level of agreement with proposed statements evaluating
satisfaction vs. “feeling energy all day” (A), “feeling at best level of energy during the whole day” (B), “feeling at the right
level of energy to face daily challenge” (C) or “feeling an energy level well balanced throughout the day” (D) from D1 to
D90 following supplementation. D—day.
3.2. Satisfaction and Perceived Stress
After 3 months of supplementation, numerical ratings related to stress perception
decreased by 2.30 points [95% CI −2.92; −1.68], relative to baseline ratings. Decreases in
NRS for stress were significant from 2 weeks after onset of supplementation (p < 0.0001 at
all times). In addition, 80% of the population was satisfied by the level of stress reduction
they experienced after 3 months, vs. 31% at study onset (data not shown).
3.3. Duration of Sleep
After 3 months of supplementation, 79% of the subjects declared sleeping between 6
h and 8 h at night; a similar percentage (80% of the subjects) was observed after 1 month
of supplementation. More than 60% of subjects observed that they did not notice any dif-
ference from their usual sleep time, only 14% of subjects reported they slept less and 12%
felt they had slept more than usual on the previous night. Only 2% of subjects agreed they
had a “feeling of energy through the day and good night sleep” at study onset, while 59%
agreed with this statement after 3 months of supplementation.
No adverse events have been reported throughout the study.
4. Discussion
Daily intake of a food supplement containing a combination of vitamins, minerals
and Panax ginseng root dry extract (G115
®
) significantly decreased the perception of fa-
tigue compared to baseline in subjects who were suffering from non-disease-related per-
sistent fatigue. This improvement was seen after two weeks and increased consistently
with the treatment duration, up to the end of the study. In particular, the general fatigue
subscale score of the MFI decreased by more than 7.55 points [95%CI −8.44; −6.66]. A de-
crease of 2.0 points is considered as the minimal clinically important difference on this
scale [35]. Feelings of physical fatigue decreased by more than one-third, and those of
mental fatigue decreased by more than one-quarter after three months. Perceived activity
and motivation levels were significantly increased, gaining around 40%; these dimensions
refer to the influence of physical and psychological factors on the level of activity and to
Int. J. Environ. Res. Public Health 2021, 18, 6257 8 of 10
the motivation needed for starting any activity. Their improvement confirmed by subjects’
own evaluations (NRS ratings of mental and physical performance) is thus a good indica-
tor that subjects feel that their physical and mental energy is supported by the supple-
mentation. Participants also self-reported enhanced satisfaction with the supplementation
regarding decreased mental and physical fatigue, as well as improvements in the level
and quality of feelings of energy.
Among the strengths of this study, one is the assessment of its primary criteria with
the MFI questionnaire, which has been validated in various population groups, including
healthy volunteers, individuals with chronic fatigue, and subjects with strenuous occupa-
tions [31,36]. The population in the current study exhibited mean general fatigue subscale
scores that were higher than those of a healthy general population (e.g., 10.8 points in
healthy Swedish women) [2] but not as high as those observed in chronic fatigue syn-
drome (e.g., 25.4 points in a group of 357 chronically fatigued patients) [31], and similar
to those observed in medical students (16.1points) or soldiers while training (17.0 points)
[31]. The findings of this study could thus be extended to populations experiencing eve-
ryday malaise (fatigue and reduced motivation), independently of a specific disease.
In addition, this study aimed at monitoring the self-perceptions of mental and phys-
ical fatigue in users of a food supplement, in real-world conditions. In particular, such
data, obtained with a validated assessment tool, have been lacking for intermediate dura-
tions of intake (15 days, 1 or 2 months) while it is suspected that supplements are often
taken for less than three months. A limitation of the study is its open-label design, which
is however consistent with the objective of the study. It was not intended to provide a
placebo-controlled demonstration of the benefits associated with the intake of Panax gin-
seng root extract G115
®
vitamin and mineral combination, which has been addressed in
other publications (for a recent review, see [19]).The improvements in self-perception and
satisfaction levels started from the second week following initiation of the supplementa-
tion and were consistently enhanced with supplement duration, up to the end of the study
period, and this adds to the body of evidence that the benefit experienced by the subjects
is real compared to initial state; one might estimate that a simple placebo effect would not
have lasted for such a long time (three months), with such a level of magnitude and in
such a sustained manner (with the proportion of satisfied participants continuing to in-
crease up to the end of the study).
5. Conclusions
Overall, this study provides new knowledge about the perception and self-evalua-
tion of fatigue and feelings of energy, using the validated MFI questionnaire, in adults
who recovered from fatigue associated with modern lifestyles, thanks to the daily intake
of a vitamin and mineral supplement containing G115
®
extract of the root of Panax ginseng.
Whilst this was not a placebo-controlled trial, the data from this study suggests both that
a full randomized controlled trial is warranted and that the endpoints identified above
would be suitable measures.
Author Contributions: A.-L.T., A.A. and E.P. conceived and conducted the study, B.B.D.F. and S.H.
performed the statistical analyses. All authors (A.-L.T., A.A., E.P., B.B.D.F., S.H., S.C., D.K. and A.S.)
reviewed, edited, and approved the final manuscript. All authors have read and agreed to the pub-
lished version of the manuscript.
Funding: The research contained in the paper has been sponsored by Sanofi-Aventis Group.
Institutional Review Board Statement: The study was conducted according to the guidelines of the
Declaration of Helsinki, and approved by Ethics Committee for Research on Medicinal Products
(CEIm) of Parc Taulí de Sabadell (Barcelona) on 25 May 2021 (code PEH18294).
Informed Consent Statement: Informed consent was obtained from all subjects involved in the
study.
Int. J. Environ. Res. Public Health 2021, 18, 6257 9 of 10
Data Availability Statement: Qualified researchers may request access to patient-level data and
related documents [including, e.g., the clinical study report, study protocol with any amendments,
blank case report form, statistical analysis plan, and dataset specifications]. Patient-level data will
be anonymized, and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access
can be found at https://www.clinicalstudydatarequest.com (last accessed 8 June 2021).
Acknowledgments: The authors kindly thank Véronique Braesco for medical writing support that
was funded by Sanofi in accordance with Good Publication Practice (GPP3) guidelines
(http://www.ismpp.org/gpp3) (last accessed 8 June 2021).
Conflicts of Interest: A.-L.T., B.B.D.F., S.H., A.A. and E.P. are current employees of Sanofi. S.C.,
D.K. and A.S. have received from Sanofi consultancy fees for activities unrelated to this publication.
S.C., D.K. and A.S. also received research funding and/or consultancy/travel/speaker fees from sev-
eral public research councils and several food or pharmaceutical companies.
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