UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055202 |
|---|---|
| Receipt number | R000062945 |
| Scientific Title | An exploratory trial of the effect of milk peptide-containing food on lipid oxidation during exercise: a randomized, single-blind, cross-over study. |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/03/24 20:06:46 |
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Basic information
Public title
An exploratory trial of the effect of milk peptide-containing food on lipid oxidation during exercise.
Acronym
An exploratory trial of the effect of milk peptide-containing food on lipid oxidation during exercise.
Scientific Title
An exploratory trial of the effect of milk peptide-containing food on lipid oxidation during exercise: a randomized, single-blind, cross-over study.
Scientific Title:Acronym
An exploratory trial of the effect of milk peptide-containing food on lipid oxidation during exercise: a randomized, single-blind, cross-over study.
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratory evaluate the effects of a single intake of foods containing milk peptides on lipid oxidation during exercise in healthy male subjects between the ages of 20 and less than 40 years who have an exercise habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lipid oxidation during exercise
Key secondary outcomes
Carbohydrate oxidation, energy expenditure, and respiratory exchange ratio during exercise, and physical fatigue after exercise
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
A single intake of 2 bottles of milk peptide-containing beverage
Interventions/Control_2
A single intake of 2 bottles of placebo beverage
Interventions/Control_3
A single intake of 2 bags of milk protein powder and 2 bottles of placebo beverage
Interventions/Control_4
A single intake of 1 bag of milk protein powder, 1 bottle of placebo beverage, and 1 bottle of milk peptide-containing beverage
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1. Male subjects between the ages of 20 and less than 40 years.
2. Subjects who have an exercise habits.
3. Subjects who have received a full explanation of the study, can understand the contents, and can give a written consent.
Key exclusion criteria
1. Subjects who exercise for competitive purposes such as participating in a tournament.
2. Subjects with extremely irregular eating habits, such as those with dietary restrictions (e.g., carbohydrate restriction, vegetarianism, etc.)
3. Subjects who have irregular life rhythms, such as shift workers and late-night workers
4. Subjects who regularly use foods for specified health use, foods with functional claims, supplements, medicines, or quasi-drugs that may affect energy metabolism
5. Subjects who have a smoking habit
6. Subjects who have participated in other clinical trials within the past 3 months and those who are currently participating in other clinical trials.
7. Subjects who suffer from or have a history of serious cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic disorders.
8. Subjects with a history of chest pain or syncope
9. Subjects who have an abnormal electrocardiogram and are judged by a physician to have a problem with exercise.
10. Subjects who have back pain, arthralgia, lumbar hernia, diseases of the lower limbs, or palpitations on exertion.
11. Subjects with drug allergy or food allergy.
12. Subjects who are judged by the investigator or sub-investigator to be inappropriate to participate in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Clinic Director
Zip code
103-0021
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9005
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co. Ltd.
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-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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 | 07 | Month | 31 | 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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062945
