Measurement of the effects of foods containing processed whey protein on metabolism in healthy subjects

UMIN ID: UMIN000054529

Registered date:02/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2024/06/03
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Phase I: Taking experimental food Wash out phase: About 1 week or more Phase II: Taking control food
Phase I: Taking control food Wash out phase: About 1 week or more Phase II: Taking experimental food

Outcome(s)

• Primary Outcome: 1. Respiratory gas analysis values (absolute and per body weight values of oxygen consumption, carbohydrate oxidation, lipid oxidation, and energy consumption, and respiratory exchange ratio) 2. The change in respiratory gas analysis values (excluding the respiratory exchange ratio) after the intake of the test food, when the values measured before the intake of the test food are set to 100%
• Secondary Outcome: [Efficacy] 1. Absolute value of the VAS questionnaire regarding the change in physical condition before and after the intake of the test food 2. The relative value of the VAS questionnaire on the change in physical condition before and after the intake of the test food, when the value measured before the intake of the test food is set as 100% [Safety] Adverse events and side effects

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 30years-old
• Gender: Male and Female
• Exclude criteria: (1)Those who regularly take specified health foods, functional foods, or health foods (including supplements) that may affect the study at least 3 times a week and cannot discontinue taking them from the time of obtaining consent (2)Those who are taking medicines (e.g. antibiotics, intestinal preparations, laxatives, etc.) at least 3 times a week that could potentially affect the study and who are unable to limit their use of such medicines during the study period (3)Heavy drinkers of alcohol (4)Those with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc (5)Pregnant, lactating, or intending to become pregnant during the study period (6)Persons with allergies (dairy, egg, soy, shrimp, crab, wheat, pork, chicken) (7)Persons who are deemed unsuitable for participation in the study by the study's principal investigator

Related Information

• Primary Sponsor: Hirosaki University
• Source(s) of Monetary Support: UHA mikakuto. Co., Ltd