UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059351 |
|---|---|
| Receipt number | R000067880 |
| Scientific Title | Effect of Imidazole Dipeptide Supplementation on Lipid Metabolism During Aerobic Exercise |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/15 12:02:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Imidazole Dipeptide Supplementation on Lipid Metabolism During Aerobic Exercise
Acronym
Effect of Imidazole Dipeptide Supplementation on Lipid Metabolism During Aerobic Exercise in Collegiate Rugby Players
Scientific Title
Effect of Imidazole Dipeptide Supplementation on Lipid Metabolism During Aerobic Exercise
Scientific Title:Acronym
Effect of Imidazole Dipeptide Supplementation on Lipid Metabolism During Exercise
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study examines the effects of four-week continuous imidazole dipeptide intake on lipid metabolism during aerobic exercise and on changes in oxidative stress markers before and after exercise in male university students who belong to the university rugby club.
Basic objectives2
Others
Basic objectives -Others
The study is designed as a double-blind, controlled trial. Prior to the intervention, participants will undergo measurement of maximal oxygen uptake (VO2max). Before and after imidazole dipeptide supplementation, a 40-minute cycling exercise at 65% VO2max will be performed. During exercise, respiratory gas parameters and heart rate will be continuously monitored to evaluate changes in lipid metabolism. Body composition and oxidative stress markers in finger-prick capillary blood also will be measured before and after exercise.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the respiratory exchange ratio (RER) during a 40 min cycling bout at 65% of VO2ma from baseline to post supplementation (4 weeks).
Key secondary outcomes
Body composition (weight, body fat percentage, fat-free mass; InBody 470) assessed at baseline and after 4 weeks; oxidative stress and antioxidant capacity in finger-prick capillary blood (FREE CARRIO DUO) measured before and after the exercise bout at each time point.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Imidazole dipeptides (carnosine/anserine=1:3), 2.0g/day for 4 weeks, administered as a flavored powder in two 2.5g sachets per day.
Interventions/Control_2
Placebo powder (identical appearance, taste, and weight) without the active ingredient imidazole dipeptides replaced with dextrin, for 4 weeks, administered as a flavored powder in two 2.5g sachets per day.
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Male university students aged 18 to 25.
2. No history of major injury or surgery within the past six months.
3. Deemed safe to participate by the physician based on self-reported medical history and medication use.
Key exclusion criteria
1. History of cardiovascular, respiratory, or metabolic diseases
2. Allergies to supplement ingredients (e.g., chicken-derived protein, beta-alanine)
3. Current use of substances listed on the 2025 WADA Prohibited List
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kaburagi |
Organization
Daito Bunka University
Division name
Faculty of Sports and Health Sciences
Zip code
355-8501
Address
Iwadono 560, Higashimatsuyama, Saitama
TEL
09054465497
t-kabu@ic.daito.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kaburagi |
Organization
Daito Bunka University
Division name
Faculty of Sports and Health Sciences
Zip code
355-8681
Address
Iwadono 560, Higashimatsuyama, Saitama
TEL
03-5399-7830
Homepage URL
kenkyu@jm.daito.ac.jp
Sponsor or person
Institute
Daito Bunka University
Institute
Department
Personal name
Funding Source
Organization
Daito Bunka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
TOKAI BUSSAN Co.,LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Research Promotion, Daito Bunka University
Address
1-9-1 Takashimadaira, Itabashi-ku, Tokyo
Tel
03-5399-7830
kenkyu@jm.daito.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
DHR25-015-1
Org. issuing International ID_1
Daito Bunka University Ethics Review Committee for Life Sciences and Medical Research Involving Human Subjects
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大東文化大学 東松山キャンパス（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 09 | 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 | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067880
