Journal of Functional Foods 97 (2022) 105228

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Journal of Functional Foods
journal homepage: www.elsevier.com/locate/jff

Anti-fatigue effect of OM-X, fermented plant extract with lactic acidbacteria and bifidobacteria: A randomized, placebo-controlled,
double-blind, comparative study
Takeshi Kaneko a, *, Akinobu Miyata b, Muneaki Takahata cabcJapan Clinical Trial Association (JACTA), 5F, Forecast Shinjuku South Bldg. 4-3-17 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan
Miyata Medical Clinic, 9F, Tokyo Fugetsudo Nihonbshi Bldg. 2-2-8 Nihonbshi, Chuo-ku, Tokyo 103-0027, JapanBIOBANK Co., Ltd., 388-1 Hirata, Kita-ku, Okayama City, Okayama 700-0952, JapanA R T I C L E I N F O

A B S T R A C T

Keywords:
Anti-fatigue
Fermented plant extract
Lactic acid bacteria
Bifidobacterial
Chalder fatigue scale

The objective of this study is to elucidate how the OM-X made from many kinds of plants fermented using lactic
acid bacteria (LAB) and bifidobacteria contributes to anti-fatigue. A randomized, placebo-controlled, doubleblind, comparative study design was adopted. We investigated the effects of 12-week ingestion of the test food orplacebo. Visual analogue scale (VAS) and Chalder fatigue scale (CFS) were examined to evaluate the feeling of
fatigue, and diacron-reactive oxygen metabolites (d-ROMs) and Biological Antioxidant Potential (BAP) were
measured to appraise comprehensive antioxidative ability. We also evaluated the safety of the food. As a result,significant differences between the two groups were detected in VAS and CFS. No safety-related matter occurred.
It turned out that the ingestion of OM-X improved feelings of fatigue for healthy people with temporary fatigue.
Additionally, there was no adverse effect by the ingestion of the food.

1. Introduction
We often feel fatigued in our daily lives. Fatigue indicates conditionsof lack of energy, low vitality, decreased motivation, etc., so that it af­
fects the amount of daily activity considerably. On the other hand, theconstitution of the WHO defines it as “a state of complete physical,
mental and social well-being and not merely the absence of disease or
infirmity” (World Health Organization, 1948). In other words, feeling
tired means not to be sick, but far from being healthy. Fatigue is known
to be caused by oxidation (Lee et al., 2018) and decreased liver function(Swain, 2006), and functional food ingredients are attracting attention
for prevention and treatment. In recent studies, traditional plants (Leeet al., 2015), green tea (Murase et al., 2005), astaxanthin (Ikeuchi,
Koyama, Takahashi, & Yazawa, 2006), and fucoidan (Chen et al., 2015)
have demonstrated beneficial effects in the suppression of fatigue
accumulation.
Furthermore, in recent years, the beneficial effects of fermented
foods on health have been attracting scientific attention. The com­pounds produced by the bacteria responsible for fermentation are wellknown to have many health benefits, including antioxidant and antiinflammatory effects (Şanlier, Gökcen, & Sezgin, 2019). OM-X is a fer­
mented dietary supplement that was developed by Dr. Iichiroh Ohhira,which has been sold not only in Japan but also in Southeast Asia,
Europe, and the United States for more than 30 years. It is made frommany kinds of vegetables, fruits, seaweeds, and mushrooms fermented
using 12 strains of LAB and bifidobacteria. Nutritionally, OM-X provides
carbohydrates (oligosaccharides and dietary fiber), fats (short-chain
fatty acids), proteins, amino acids, some vitamins, minerals, and poly­
phenols. In human clinical studies, OM-X has shown beneficial effects onbone health (Kawakami et al., 2003), oral ulcerations (Hashim, Rahman,& Philip, 1999), and athletic performance (Kawakami et al., 1998).
Therefore, in the current study, we report on a 12-week long-term
intake, a randomized, placebo-controlled, double-blind, comparative
study to examine how OM-X affects people’s fatigue.

Abbreviations: LAB, lactic acid bacteria; CFS, chalder fatigue scale; VAS, visual analogue scale; d-ROMs, diacron-reactive oxygen metabolites; BAP, biologicalantioxidant potential; TH10, Enterococcus faecalis TH10; FOSHU, food for specified health uses; ATP, adenosine triphosphate; ROS, reactive oxygen species.
* Corresponding author at: Japan Clinical Trial Association (JACTA), 5F, Forecast Shinjuku South Bldg. 4-3-17 Shinjuku, Shinjuku-ku, Tokyo 160-0022, Japan.
E-mail address: jacta@usjri.com (T. Kaneko).
https://doi.org/10.1016/j.jff.2022.105228
Received 13 July 2022; Received in revised form 18 August 2022; Accepted 18 August 2022
Available online 27 August 2022
1756-4646/© 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/bync-nd/4.0/).

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Journal of Functional Foods 97 (2022) 105228

2. Materials and methods

organic acids and carbohydrates in OM-X.

2.1. Study design

2.5. Experimental procedures

A randomized, placebo-controlled, double-blind paralleled design
was implemented from August to November 2021 at Japan Clinical Trial
Association; JACTA, Tokyo. This trial was registered at UMIN Clinical
Trial Registry as UMIN000045191.

Subjects in Group A ingested Active and those in the other Group B
took in Placebo, both had 3 softgel capsules once a day for 12 weeks. All
subjects were instructed as follows: to take the assigned foods as indi­cated; to maintain their usual lifestyle and habits; to avoid excessive
amounts of food, drink, or alcohol; to avoid any medicine or FOSHU(food for specified health uses) that aimed at anti-fatigue; to maintain adaily record of their physical condition, sleeping, appetite, and exercise;and to send the diary once a week to the study coordinator.

2.2. Participants
Healthy subjects participated in the present study. All of the subjects
in this study were public volunteers who enrolled in the monitor bank of
InCROM Inc. (Nishiwaki, Hyogo), recruited from July through August2021.
The inclusion criteria were as follows: (1) Healthy Japanese males
and females from 40 to 59 years of their age; (2) Subjects aware of
temporary fatigue. The exclusion criteria were as follows: (1) Subjects
with chronic fatigue or diagnosed chronic fatigue syndrome; (2) Sub­
jects with serious cerebrovascular disease, heart disease, liver disease,renal disease, gastrointestinal disease, psychiatric disease, or designatedinfectious diseases; (3) Subjects receiving treatment (hormone replace­ment therapy, drug therapy, exercise therapy, diet therapy, etc.) or those
who are judged to be need of treatment at a time of receipt of informed
consent. (4) Subjects with continuous usage of supplements and/or
functional foods affecting fatigue, including food for specified healthuses (FOSHU); (5) Subjects with drugs or food allergies; (6) Subjects
with a history of alcohol dependence or drug dependence; (7) Smoker1;(8) Pregnant, or those who plan to become pregnant during the study, orwith breastfeeding; (9) Subjects who have participated in other clinical
trials 1 month prior to receipt of informed consent, or those who plan toenroll in other clinical trials during this trial; (10) Subjects who plan tovaccination for COVID-19 within 7 days before the visit; (11) Subjects
who are judged as unsuitable for the study by the principal investigator.

2.6. Outcome
The objective of this study was to elucidate the improvement of afeeling of fatigue by the ingestion of the food made of fermented plant
extract with LAB and bifidobacteria. To evaluate this objective, VAS(Visual analog scale), Chalder fatigue scale (CFS) were measured as theprimary outcome. Furthermore, as the secondary outcomes, d-ROMs and
BAP test by blood, and safety of the food were determined. These
measurement outcomes except safety evaluation were conducted upon
pre and post-intervention.
2.6.1. VAS
After visiting examination room, the subject sat in a chair and indi­cated the degree of fatigue in these 7 days by a x-mark on the horizontal
line with a length of 10 cm written on the VAS paper on the desk, whichline meant that the left end was “the best feeling without feeling tired atall” and the right end was “the worst tired enough to do nothing”. The
distance from the left end to the x-mark (unit: cm, up to 5/100) was
measured and evaluated as a VAS score. In each VAS exam, we adopted
an independent entry method that marked without looking at the pre­vious record.

2.3. Randomization

2.6.2. CFS
Fatigue level was evaluated using the Chalder fatigue scale (CFS)(Chalder et al., 1993) Japanese version. This scale consists of 14 factorsof physical fatigue and mental fatigue, and adopted Likert-scale fromnone (1 point) to very high (4 points), 56 points of full points.2 The
higher the score, the higher fatigue level.

According to inclusion/ exclusion criteria, 40 subjects were selected
and sequentially allocated to two groups by 20 each using a random
number table. Among those, 2 of the Group A declined to participate in
the study, and remained 38 subjects launched allocated intervention. In
the process of assignment by the person in charge, background factors
such as gender and age were taken into consideration to avoid biased
distribution. The allocation list was sealed and strictly controlled until
the end of the study. Subjects in Group A received the test sample(Active) and subjects in the Group B received Placebo. As shown in
Fig. 1.

2.6.3. d-ROMs and BAP
The d-ROMs (diacron-reactive oxygen metabolites) and the BAP(Biological Antioxidant Potential) were measured from subject’s blood.
The d-ROMs can evaluate oxidative stress inclusively in the living bodyby assaying the concentration of hydroperoxide (ROOH) in the blood(Seki, 2009). The BAP evaluates antioxidant capacity by assaying the
reducing ability, that antioxidants in plasma donate electrons to active
oxygen to prevent the oxidation reaction (Dohi et al., 2005). Both dROMs and BAP were measured using an active oxygen/ free radical
automatic analyzer (free radical analytical system: FRAS, Wismerll
Company Limited). In addition, the modified BAP/ d-ROMs ratio was
calculated to appraise antioxidative ability of the living body compre­
hensively (Nagata et al., 2008) 15). The modified BAP/ d-ROMs ratio
represents the balance of the antioxidation, which is BAP divided by dROMs and further divided by coefficient of 7.541. The higher this value,
the more defensive from oxidative stress (Nagata et al., 2008).

2.4. Test foods
The test food, OM-X is made of the fermented extract, which consistsof several kinds of Japanese plants with 12 kinds of LAB and bifido­
bacteria such as TH10. Fulvic acid, D-amino acids, L-amino acids, mel­anoidin, polyphenols, organic acids, fatty acids, vitamins, minerals,
dietary fibers, oligosaccharides, LAB, and bifidobacteria are included in
the Active. The placebo was made chiefly from safflower oil. To evaluate
the effectiveness of OM-X as a whole, we did not add neither fermented
extracts nor LAB as base ingredients for OM-X. The amount of daily
intake was 3 softgel capsules (1 capsule weighs 580 mg). Both Active
and placebo, which were prepared by BIOBANK Co., ltd., were indis­
tinguishable in shape, color, or taste, and were managed by identifica­tion marks, thus all involved were blinded. Table 1-1 and Table 1-2 show
the ingredients contained in OM-X production and the composition of
1

2.6.4. Safety
The safety of the test food was evaluated utilizing a written ques­tionnaire during the study. Any untoward medical occurrence during thestudy period in participants has defined an adverse event; it does not
2

Those who have smoked in the last year.
2

The original CFS adopts 0–3 point of Likert-scale, 42 points of full points.

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Journal of Functional Foods 97 (2022) 105228

Fig. 1. Flow diagram of subject disposition.
Table 1-1
Composition of food materials of making OM-X.

Table 1-2
Composition of organic acids and carbohydrates in
OM-X.

%
Fruits;Prune. fig, Chinese bayberry, Chinese matrimony, Blueberry, Yuzu (lomon)
Vegetables;
Japanese mugwort, Komatsuna
Mushrooms;
Shiitake mushroom, Maitake (dancing mushroom), Agaricus mushroom
Seaweeds;
Wakame (brown seaweed), Hijiki seaweed, Konbu (Kelp)
Sugar
LAB;
Bifidobacterium breve ss. Breve, Bifidobacterium infantis ss. Infantis,
Bifidobacterium longum, Enterococcus faecalis,
Lactobacillus acidophilus, Lactobacillus brevis,
Lactobacillus bulgaricus, Lactobacillus casei ss. casei,
Lactobacillus fermentum, Lactobacillus helvericus ss. jugurti,
Lactobacillus plantarum, Streptococcus thermophillus

g/100 g28.6

Citric acid
Lactic acid
Malic acid
Formic acidAcetic acid
Succinic acid
Propionic acid
Butyric acid
GlucoseFructose
Galactose
MannoseIsomaltose
Panose

8.6
4.1
2.7
55.4
0.6

0.18
0.11
0.10
0.06
0.05
0.02
N.D.
N.D.
8.87
6.46
0.52
0.38
0.21
0.11

3. Results

necessarily have to have a causal relationship with the test food. And theprincipal investigator determined the relations between cause andconsequence of the adverse events.

3.1. Participant demographics
The 38 subjects made a start with assigned ingestion. None of thesubjects in both groups dropped out, and all of 38 completed the study.
The test food intake rates were 100 % and 100 %, respectively. Thus,
data obtained from 38 subjects (Group A; 18, Group B; 20) were used for
efficacy analysis (Fig. 1). The subjects were 41–58 y.o., with an averageof 50.6 ± 5.0 years. There were no significant differences in genderratio, age, and CFS at baseline among groups (Table 2).

2.7. Data analysis
An ITT analysis was adopted and no sample size was used. All sta­tistics were expressed as mean ± SD. Chi-square test and Student’s t-test
were used to compare the subject’s backgrounds between groups. As formeasured value, the paired t-test was used for intragroup analysis, andStudent’s t-test was used for intergroup comparisons of changes from thebaseline (⊿0-12w). Multiplicity according to the occasions was not
adjusted. Any subjects with missing values were eliminated from theanalysis. Statistical analyses were performed using Excel Tokei 3.23
(BellCurve) and Statcel 4 (Yanai, 2015). The results were consideredsignificant at a < 5 % level in the two-sided test.

3.2. Test results
Table 3 indicates the results of measurement. As for VAS, the intra­
group analysis in Active showed significant differences, though thePlacebo depicted no significant difference. Further, there was a3

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Journal of Functional Foods 97 (2022) 105228

chemicals), biological stress (i.e., viruses, bacteria) (Kuratsune, 2006;
Kuratsune, 2010). Recent studies have elucidated that the cause of fa­
tigue in modern people is radical oxygen in the autonomic center system(Kajimoto, 2015). Humans take in oxygen by breathing, produce aden­osine triphosphate (ATP), and have the energy needed for life activities.
In these processes, a large amount of reactive oxygen species (ROS) is
produced (Nagata, 1997; Sato & Inoue, 2002). The ROS harms cells andintracellular protein components, which damages become signals toincrease immune system cytokines, thus abnormalities occur in themetabolism/ signal transduction system. It is considered through that
repairing damaged cell components requires more energy and sub­stances than is required for normal cell activity, cell repair does notproceed due to a lack of available energy and substances under fatigue
condition, metabolism/ signal transduction system worsen more andmore, and these lead to over-exhaustion or chronic fatigue (Tanaka,2009). Besides, focusing on the changes in the brain when a person feels
fatigued, it was found that the hypothalamus and anterior cingulate
gyrus region, which are the centers of the autonomic nerves of the brain,
are tired strongly. In this area, sympathetic and parasympathetic nerves
are balanced such as the following physical condition management (ex.,elevating heart rate, accelerating breath, thermoregulation), adjustmentof mental stress and relaxedness. That is to say, it is this area of the brainthat becomes tired, whether people use their own brain or body (Kaji­moto, 2015).
Since the increased radical oxygen inside of the body leads to cancer,
aging, and lifestyle diseases (Nagata, 1997; Seishima et al., 2015), it isimportant to remove the radical oxygen for health. Suppressing oxida­
tion by radical oxygen is called antioxidant. For antioxidation, anti­oxidative substances or enzymes that decompose radical oxygen are
significant. There are mentioned vitamins A, C, E, CoQ10, flavonoid
polyphenols, non-flavonoid polyphenols, sulfur compounds, and carot­
enoids as typical antioxidative substances (Japan foundation for aging
and health, 2022; Nakamura, 2013). In particular, polyphenols con­tained in plants have high antioxidant ability, and this ability is pro­portional to the amounts of polyphenols subsisted in plants (Kimura,
Yamagishi, Suzuki, & Oita, 2005). We verified anti-fatigue effect of OMX on humans in a randomized, placebo-controlled, double-blind,parallel-group trial this time. Since OM-X is produced by fermenting
plant materials with LAB over several years, numerous metabolites suchas antioxidants are produced during the fermentation period. Metab­olomic analysis has confirmed that OM-X extract contains hundreds of
low-molecular-weight compounds, including proteins, peptides, organic
acids, short-chain fatty acids, dietary fiber, vitamins (except VC), andpolyphenols (data not shown). Previous studies have shown that OM-X
extract regulates metabolic enzymes in the livers (Wakame et al.,2017), and improve muscular endurance in fatigue mice for significantly
reducing triglyceride levels in blood and increasing mRNA levels ofcarbamoyl phosphate synthetase 1 (Cps1) and arginase 1 (Arg1) in theurea cycle (Itoh et al., 2017). Furthermore, administration of OM-X
extract to mice with deficient vitamin C synthesis (SMP30/GNL
knockout mice), which is essential for antioxidant activity in the mouse
body, has been shown to improve antioxidant capacity and significantly
improve transaminase (AST, ALT) levels, which indicate deterioration ofliver function (Wakame et al., 2020). Furthermore, it is known that LAB
has an immunostimulatory activity (Perdigon et al., 1995; Morimoto
et al., 2005) and anti-allergic property (Majamaa & Isolauri, 1997), andalso has a probiotic effect of keeping the balance of intestinal bacteria
and regulating the function of intestine (Hara et al., 1993). In recent
years, studies on the relationship between LAB and anti-fatigue aremaking progress, so that the anti-fatigue effects of LAB have been
revealed (Muto et al., 2021; Makino et al., 2018). The mechanism has
deemed the action by improving the balance of the intestinal flora(Matsuo, 2015), and the brain-gut-microbiota action (Wei et al., 2021)
which LAB themselves and substances produced by LAB stimulate theintestinal canal and affect the brain (Suganya & Koo, 2020; Watanabe,2022). OM-X extract has been shown to inhibit inflammatory reactions

Table 2
Subject demographics.
Item

Unit

Group AGroup B

Subjects*
Male: Female*
Age*
CFS*

numbernumber
year
point

18
10:8
49.4 ± 5.0
15.8 ± 9.0

20
8:12
51.7 ± 4.8
16.3 ± 4.8

Values are expressed as the mean ± SD.
*
no significant difference.
Table 3
Test results.
amount of change (⊿0-12w)1
outcomep-value

Unit

Active (n =18)

Placebo (n =
20)

VAS

score

0.10 ± 2.58

0.004

CFS
d-ROMspoint
U.CARR− 0.2 ± 3.2
5.3 ± 125.8

0.043 #
0.499

BAP

μmol/lratio− 230.5 ±970.3
0.15 ± 5.14

0.185

modified BAP/ d-ROMs
ratio− 2.41 ± 2.45**
− 2.2 ± 2.5 **− 20.9 ±109.1
103.3 ±
417.1
4.25 ± 15.23

3

2

##

0.264

Values are expressed as the mean ± SD.
1** p < 0.01 against pre-ingestion.
2 #p < 0.05, ## p < 0.01 between-group difference.
3
an arbitrary unit (1U.CARR = 0.08 mg/ 100mlH2O2).

significant difference between the two groups. CFS indicated significant
differences within Active, and in intergroup analysis among Active andPlacebo. There were no significant differences in both intra and inter­group comparisons of the d-ROMs, the BAP, and the modified BAP/ dROMs ratio.
3.3. Adverse event
No adverse events associated with the test food were observed in thecourse of the reporting.
4. Discussion
We conducted a randomized, placebo-controlled, double-blind,comparative study for examining the effect of the OM-X made frommany kinds of plants fermented using LAB and bifidobacteria on feelingsof fatigue. The ingestion of 3 softgel capsules of the OM-X improved the
VAS and CFS significantly. Additionally, the comprehensive anti­oxidative ability (modified BAP/ d-ROMs ratio) increased, although
there was no significant difference between the groups. Furthermore, nosafety-related matter occurred during the test period.
The Japanese society of fatigue science defines “fatigue as a state ofdecreased physical activity with peculiar discomfort and desire for rest,
caused by excessive physical and mental activity, or illness” (Japanesesociety of fatigue science, 2011). In other words, fatigue means adecrease in activity ability caused by overloading on mind and body,and that indicates symptoms such as decreased thinking ability, reduced
response to stimuli, impaired attention, distraction, slow movement,
decreased activity, blurred vision, headache, stiff shoulders, and low
back pain. Fatigue is divided into physical fatigue (means peripheral
fatigue) and fatigue felt mainly by the brain (means central fatigue).
Both fatigues are caused by the imbalance of the endocrine system suchas nervous system, immune system, and hormones in the body, which
imbalance is due to mental stress (i.e., human relationship, working
relationship), bodily stress (i.e., overwork), physical stress (i.e., ultra­
violet rays), chemical stress (i.e., chemical agent, residual agricultural4

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Journal of Functional Foods 97 (2022) 105228

in the intestinal tract in mice with induced intestinal inflammation andto promote the formation of tight junctions and intestinal epithelium(Takahata et al., 2014).
Bifidobacteria contained in OM-X representing probiotics along with
LAB has revealed many clinical effects related to immune function. For
instance, B. longum BB536 is known to have an anti-hay fever effect(Xiao et al., 2007), an anti-influenza effect (Namba et al., 2010), andulcerative colitis improving effect (Takeda et al., 2009). It is also
thought that bifidobacteria suppress immune responses such as Th1,
Th2, and Th17, and induce regulatory T cells (Tregs) involved in the
induction of immune tolerance (Kwon et al., 2010). In addition, it isreported that acetic acid, which is a metabolite of bifidobacteria, has apreventive effect on O-157 in mice (Fukuda et al., 2011). Ameliorating
effect of B. bifidum BGN4 and B. longum BORI on cognitive function inmice (Kim et al., 2021), and improvement effect of a mixture of LAB(L. fermentum LF16, L. rhamnosus LR06, L. plantarum LP01) and bifido­
bacteria (B. longum BL04) on human depression and quality of sleep(Marotta et al., 2019) were reported, thus the effects of bifidobacteria on
the brain have also been suggested. The following is an analogy that thevarious antioxidants, LAB, and bifidobacteria contained in OM-X may
have suppressed oxidation caused by active oxygen, improved the bal­ance of the intestinal environment, and suppressed inflammation,
thereby improving the balance of the autonomic nervous system andproducing an anti-fatigue effect.
In this study, VAS and CFS were used as scales of fatigue. The Jap­
anese society of fatigue science previously mentioned has developed theguideline for clinical evaluation of anti-fatigue, and cited VAS and CFS
as subjective evaluation indexes for effectiveness trial (Japanese societyof fatigue science, 2011). VAS was formulated mainly in the field ofanesthesiology to objectively evaluate subjective symptoms which are
difficult to measure (i.e., pain sensation), and the availability of the scale
has been established (Ministry of Health, Labour and Welfare, 2020).
Recently, VAS has also been used as a scale of health-related QOL and
fatigue, and has been employed in many studies such as food function­ality evaluation (Tsuda et al., 2019; Najima & Miyata, 2018; Shimizu,
Fukuda, & Yamamoto, 2009; Kim et al., 2013). CFS is a scale reported by
Chalder et. al. (Chalder et al., 1993), and the reliability and validity of
the Japanese version have also been admitted (Tanaka et al., 2008). As
with VAS, CFS is widely used in domestic and international study(Holton et al., 2020; Kushima et al., 2021; Pöttgen et al., 2018; Shimizu
et al., 2009). Additionally, the Japanese society of fatigue science lists dROM (oxidative stress) (Seki, 2009) and BAP (antioxidative ability)(Dohi et al., 2005) as scales of oxidative stress (Japanese society of fa­
tigue science, 2011). Prof. Nojima (2011) reported as the oxidative
stress value (d-ROMs value) increased, the antioxidative ability (BAP
value) to control that oxidative stress decreased, and the long-increasingoxidative stress level strongly related to the pathological formation ofchronic fatigue (Nojima, 2011). In late years, the modified BAP / dROMs ratio has been used as a scale of comprehensive antioxidant
ability (Imai, Kobayashi, & Uenishi, 2021; Morimoto et al., 2020). As aresult of our study, it is thought that the considerable elevation ofmodified BAP / d-ROMs ratio in active indicates the anti-fatigue effect of
OM-X. On the other hand, although the d-ROM, BAP, and modified BAP/
d-ROMs ratios inactive greatly improved all, no significant differencecame out between the groups. It is presumed that the dispersion in theindividual subjects was high. Since this study targeted healthy adults
with temporary fatigue, there could be a low difference in before- andafter compared to sick. An objective evaluation method of fatigue forhealthy people remains to be seen. In addition, our primary goal was toevaluate the effect of OM-X itself this time, thus we dared to study theeffect of each individual ingredient (fermented extract, LAB, or bifido­
bacteria) in a separate study to be followed.

made of fermented plant extract with LAB and bifidobacteria mightameliorated the feeling of fatigue for healthy people with temporary
fatigue. In addition, no adverse event was triggered by the test food.
Ethics statements
The authors ensure that the current clinical trial has been carried out
in accordance with the ethical principles of the declaration of Helsinki
and the Ethical Guidelines for Medical and Health Research Involving
Human Subjects. The protocol was approved by the Institutional Review
Board of Pharmaceutical Law Wisdoms, Tokyo, and was conducted incompliance with the protocol. Written informed consent was obtained
from all subjects prior to enrolment.
Funding
This work was supported by BIOBANK Co., ltd., Okayama, Japan.
CRediT authorship contribution statement
Takeshi Kaneko: Formal analysis, Investigation, Data curation,
Writing – original draft, Writing – review & editing, Visualization,
Project administration, Funding acquisition. Akinobu Miyata: Meth­odology, Validation, Investigation, Data curation, Writing – review &editing, Supervision. Muneaki Takahata: Conceptualization.
Declaration of Competing Interest
The authors declare that they have no known competing financial
interests or personal relationships that could have appeared to influence
the work reported in this paper.
Data availability
Data will be made available on request.
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5. Conclusion
In conclusion, we found out that the 12-week ingestion of OM-X
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