UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059841 |
|---|---|
| Receipt number | R000068430 |
| Scientific Title | Investigation of the effect of test food intake on fatigue reduction after exercise load |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/20 18:00:12 |
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Basic information
Public title
Investigation of the effect of test food intake on fatigue reduction after exercise load
Acronym
Investigation of the effect of test food intake on fatigue reduction after exercise load
Scientific Title
Investigation of the effect of test food intake on fatigue reduction after exercise load
Scientific Title:Acronym
Investigation of the effect of test food intake on fatigue reduction after exercise load
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the fatigue-reducing effect of oligosaccharide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue VAS
Key secondary outcomes
1. Defecation status (presence or absence of defecation, frequency, time of defecation, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor)
2. Gut microbiota
3. Gut metabolomes
4. Abdominal symptoms (bloating, belching, gas(flatus frequency)) at times other than during defecation
5. RPE
6. POMS2 Japanese version, Short Form
7. Blood biochemical parameters (CK, GLU, Lactic acid, Free fatty acids)
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
Consumption of test food for 8 weeks
Interventions/Control_2
Consumption of placebo food for 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
Key inclusion criteria
(1) At informed consent, male subjects aged more than or equal to 20, and less than 65 years old.
(2) Subjects who habitually exercise once or twice a week (exercise of 5 METs or more for 30 minutes or more, excluding resistance training).
(3) Subjects who can continue their exercise habits from before study participation during the study period.
(4) Subjects who can consume coffee daily.
(5) Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study.
Key exclusion criteria
(1) Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods that may affect the study (fatigue-reducing effect, intestinal regulation, etc.) from the time consent is obtained.
(2) Subjects who are unable to discontinue consumption of supplements (including powder, tablets, capsules, and other forms distinct from ordinary foodstuffs, taken for nutritional or functional purposes regardless of ingredients or functionality) from the time consent is obtained.
(3) Subjects who have taken drugs (antibiotics, intestinal regulators, laxatives, etc.) that would affect the study one month prior to the pre-test, or those who plan to take them during the study.
(4) Subjects with a tendency for constipation (defecation frequency of 5 times or less per week) or a tendency for diarrhea (more than half of weekly defecations are mushy or watery stools) at the background survey.
(5) Subjects with a history of appendectomy.
(6) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent.
(7) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study.
(8) Subjects with extremely irregular eating habits or lifestyle rhythms.
(9) Subjects whose roommates plan to participate in the study.
(10) Subjects who have smoked within the past year.
(11) Heavy alcohol drinkers.
(12) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
(13) Subjects allergic to medicines and foods.
(Due to character limitation, the following will be listed in the "Others" section)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Nomaguchi |
Organization
Metagen, Inc.
Division name
Product Development Support Division
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata 997-052, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Division
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo, Japan
TEL
+81-3-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto AGF, 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan
Tel
+81-3-6225-9005
IRB@cpcc.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
| 2025 | Year | 11 | Month | 20 | 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
| 2025 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Continuing from exclusion criteria)
(14) Participating in a clinical study of another drug or health food, within 4 weeks of the completion of the study, or who is scheduled to participate in another clinical study after consent to participate in this study.
(15) Subjects who have donated 200 mL of blood in one month before the start of the study.
(16) Subjects who have donated 400 mL of blood within 3 months before the start of the study.
(17) Subjects whose blood collected in the 12 months before the study, plus the expected total blood volume for the study, exceeds 1200 mL.
(18) Those who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.
Management information
Registered date
| 2025 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068430
