Tokyo, June 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058104) titled 'A Trial to Evaluate the Effects of Continuous Consumption of a Food Product Containing Milk Peptides on Fat Oxidation During Exercise' on June 6.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - CPCC Company Limited

Condition: Condition - Male adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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

Eligibility: Age-lower limit - 20 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 Size - 30

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066240

Disclaimer: Curated by HT Syndication.