UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062886 |
|---|---|
| Receipt number | R000071753 |
| Scientific Title | A Study on the Effects of a Test Food on Fatigue and the Gut Microbiome - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial - |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/08/25 10:11:57 |
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Basic information
Public title
A Study on the Effects of a Test Food on Fatigue and the Gut Microbiome
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial -
Acronym
A Study on the Effects of a Test Food on Fatigue and the Gut Microbiome
Scientific Title
A Study on the Effects of a Test Food on Fatigue and the Gut Microbiome
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial -
Scientific Title:Acronym
A Study on the Effects of a Test Food on Fatigue and the Gut Microbiome
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of continuous consumption of the test food on daily fatigue and the intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Chaldar Fatigue Scale
2) Fatigue VAS Questionnaire
3) POMS2 Japanese Version
4) Gut Microbiome Analysis
Key secondary outcomes
1) Physical Examination
2) Clinical Tests
3) Physician Interview/Adverse Event Assessment
4) Daily Activity Log
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of a test food (2 capsules in a day; 8 weeks).
Interventions/Control_2
Oral ingestion of a control food (2 capsules in a day; 8 weeks).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women who are 20 years of age or older but under 65 at the time consent to participate in the study is obtained.
2) Healthy individuals with no chronic physical illnesses.
3) Individuals who experience physical or mental fatigue in their daily lives.
4) Individuals who have received a thorough explanation of the study's purpose and content, possess the capacity to give informed consent, have voluntarily agreed to participate after fully understanding the study, and are able to provide written consent to participate in the study.
5) Individuals who are able to visit the facility on the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in the study by the principal investigator.
Key exclusion criteria
Individuals
1) with chronic fatigue.
2) who have fewer than three spontaneous bowel movements per week.
3) suffering from any medical condition and currently undergoing drug therapy.
4) with a current history of mental illness, sleep disorders, hypertension, diabetes, or dyslipidemia, or individuals with a history of serious illness, whether past or present.
5) with a history of serious conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system.
6) who within the past month, have taken or applied medications for the purpose of treating a medical condition.
7) who regularly take medications that affect the gut microbiome.
8) with a BMI of 30 kg/m2 or higher.
9) who may experience allergic reactions to ingredients contained in the test food, as well as individuals who may experience allergic reactions to other foods or medications.
10) whose daily alcohol consumption exceeds an average of 40 g per day for men and 20 g per day for women, calculated on a weekly basis.
11) who may change their lifestyle habits during the trial period.
12) who currently have, or have had within the past 3 months, a habit of regularly consuming health functional foods, health foods, or supplements, as well as individuals who plan to consume such products during the trial period.
13) who have donated whole blood or blood components in an amount exceeding 200 mL within the past month or 400 mL within the past three months.
14) who are pregnant, breastfeeding, or who may be pregnant, or who intend to become pregnant during the study period.
15) currently participating in another human clinical trial, or individuals for whom three months have not yet elapsed since participating in another human clinical trial.
16) whose themselves or family members are employed by a company that develops, manufactures, or sells health or functional foods and cosmetics.
17) Any other individuals deemed ineligible for this trial by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Amami |
Organization
Life Science Research Institute, Inc.
Division name
Representative Director
Zip code
152-0012
Address
2-15-14 Senzoku, Meguro-ku, Tokyo 152-0012, JAPAN
TEL
+81-3-3725-0166
dr-amami@hotmail.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Life Science Research Institute, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071753
