Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055202) titled 'An exploratory trial of the effect of milk peptide-containing food on lipid oxidation during exercise' on July 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Healthy male adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 20
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 Size - 40
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062945
Disclaimer: Curated by HT Syndication.
