UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061868 |
|---|---|
| Receipt number | R000070688 |
| Scientific Title | The effects of test foods containing peptides on reducing fatigue in healthy adults: a randomized, double- blind, placebo-controlled, parallel-group, dose finding study |
| Date of disclosure of the study information | 2026/07/29 |
| Last modified on | 2026/06/11 13:59:22 |
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Basic information
Public title
Dose-finding study of test foods containing peptides for reducing fatigue in healthy adults
Acronym
Dose-finding study of peptides for reducing fatigue
Scientific Title
The effects of test foods containing peptides on reducing fatigue in healthy adults: a randomized, double- blind, placebo-controlled, parallel-group, dose finding study
Scientific Title:Acronym
The effects of test foods containing peptides on reducing fatigue in healthy adults
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of test foods containing peptides on subjective fatigue in healthy adults by comparing two different doses of test foods with a placebo
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue VAS (Visual Analogue Scale)
Key secondary outcomes
Profile of Mood States 2nd Edition
Chalder Fatigue Questionnaire
OSA sleep inventory MA version 5-factor score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of peptide-containing food (low dose) daily for 4 weeks
Interventions/Control_2
Intake of peptide-containing food (medium dose) daily for 4 weeks.
Interventions/Control_3
Intake of Placebo daily for 4 weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who are aware of experiencing fatigue in their daily life
Individuals who have provided prior informed consent
Key exclusion criteria
Individuals who are receiving treatment for chronic fatigue
Individuals who are undergoing any medical treatment at a healthcare facility, including pharmacotherapy or treatment by a specialist
Individuals with a current or past history of serious diseases
Individuals who habitually consume pharmaceuticals, supplements, fortified foods, or vitamin products
Individuals with a current or past history of drug or food allergies (including those who may develop allergic reactions to the test food)
Individuals who participated in another clinical trial within one month prior to consent, are currently participating, or plan to participate during the study period
Individuals who habitually consume excessive amounts of alcohol (equivalent to 60 g/day of alcohol)
Individuals who smoke
Individuals who engage in night-shift work
Individuals deemed inappropriate for participation in this study by sub-investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Sciences
Zip code
819-0395
Address
744 Motooka, Nishi-ku, Fukuoka, Japan
TEL
092-802-4675
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Nagae |
Organization
Faculty of Agriculture, Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Sciences
Zip code
815-8540
Address
Room 403, Open Design Laboratory Building 2 4-9-1, Shiobaru, Minami-Ku Fukuoka City
TEL
092-553-9458
Homepage URL
sffps.hitoshiken@agr.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
3G Science LLC
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, JAPAN
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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 | 07 | Month | 29 | 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 | 05 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070688
