UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058104 |
|---|---|
| Receipt number | R000066240 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Effects of Continuous Consumption of a Food Product Containing Milk Peptides on Fat Oxidation During Exercise |
| Date of disclosure of the study information | 2026/06/06 |
| Last modified on | 2026/04/28 17:32:33 |
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Basic information
Public title
A Trial to Evaluate the Effects of Continuous Consumption of a Food Product Containing Milk Peptides on Fat Oxidation During Exercise
Acronym
A Trial to Evaluate the Effects of Continuous Consumption of a Food Product Containing Milk Peptides on Fat Oxidation During Exercise
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Effects of Continuous Consumption of a Food Product Containing Milk Peptides on Fat Oxidation During Exercise
Scientific Title:Acronym
A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Effects of Continuous Consumption of a Food Product Containing Milk Peptides on Fat Oxidation During Exercise
Region
| Japan |
Condition
Condition
Male adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of continuous consumption of a food product containing milk peptides on fat oxidation during exercise in healthy males aged 20 to under 40 years with a tendency toward obesity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indicators related to fat oxidation during exercise (fat oxidation rate and respiratory exchange ratio).
Key secondary outcomes
Fat oxidation rate and respiratory exchange ratio at rest
Carbohydrate oxidation and energy expenditure at rest and during exercise
Physical fatigue before and after exercise
Base
Study type
Interventional
Study design
Basic design
Cross-over
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 consumption of the test food (2 sachets, once daily) for 4 weeks
Interventions/Control_2
Oral consumption of the placebo food (2 sachets, once daily) for 4 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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1. Male aged 20 to below 40 years.
2. Individuals with a body mass index (BMI) of 25.0 kg/m2 or more and less than 30.0 kg/m2.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who are following dietary restrictions (e.g., low-carbohydrate diets, vegetarian diets) or have extremely irregular eating habits.
2. Individuals with irregular daily routines, such as shift workers or those who work night shifts.
3. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, dietary supplements, medications, or quasi-drugs that may affect energy metabolism.
4. Individuals who are currently smoking or who have smoked within the past year.
5. Individuals who consume alcohol at least once a week.
6. Individuals who engage in exercise for 30 minutes or more at least twice per week.
7. Individuals who have participated in another clinical trial within the past 3 months or are currently participating in another clinical trial.
8. Individuals who have been diagnosed with or have a history of severe cardiovascular disease, hepatic dysfunction, renal dysfunction, respiratory disorders, endocrine disorders, or metabolic disorders.
9. Individuals with a history of chest pain or syncope.
10. Individuals with electrocardiographic abnormalities that a physician deems to interfere with exercise.
11. Individuals with low back pain, joint pain, lumbar disc herniation, lower limb disorders, or who experience palpitations during physical exertion.
12. Individuals with known allergies to drugs or foods.
13. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
30
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, 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
| 2026 | Year | 06 | Month | 06 | 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
30
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
| 2025 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066240
