Evaluation of the improvement in physical function by high 11S globulin content soybeans in healthy middle-aged and elderly individuals with low physical activity levels

UMIN ID: UMIN000055799

Registered date:06/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy middle-aged and elderly Individuals
• Date of first enrollment: 2025/01/06
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Specifics of the intervention act (high 11S globulin content soybeans in blended diet 100g /day, administration period of 28 days) Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (allergic symptoms, etc.) occurs due to ingestion Criteria for discontinuation or completion of the intervention (prophylaxis, testing, etc.); discontinuation if any intake-related discomfort (allergic symptoms, etc.) occurs
Specifics of the intervention act (milk protein in blended diet 100g /day, administration period of 28days) Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (allergic symptoms, etc.) occurs due to ingestion Criteria for discontinuation or completion of the intervention (prophylaxis, testing, etc.); discontinuation if any intake-related discomfort (allergic symptoms, etc.) occurs
Specifics of the intervention act (placebo in blended diet 100g /day, administration period of 28days) Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (allergic symptoms, etc.) occurs due to ingestion Criteria for discontinuation or completion of the intervention (prophylaxis, testing, etc.); discontinuation if any intake-related discomfort (allergic symptoms, etc.) occurs

Outcome(s)

• Primary Outcome: Lean body mass (Muscle mass) Quadriceps Volume by MRI Muscle Strength Walking Time and Speed
• Secondary Outcome: Muscle Atrophy Marker Oxidative Stress Marker

Key inclusion & exclusion criteria

• Age minimum: 45years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: Individuals with myogenetic diseases Individuals with moderate or severe renal dysfunction (including those with diabetes) Individuals with dietary protein restrictions Individuals receiving medications that affect muscles, such as corticosteroids Individuals with allergies (especially soy, milk and pollen allergies) Individuals taking health supplements containing soy or protein Individuals with pacemakers, claustrophobia, or other conditions that prevent MRI examinations Individuals who refuse to participate in the study Individuals deemed by the principal investigator to be unable to participate in the study

Related Information

• Primary Sponsor: The University of Tokushima
• Source(s) of Monetary Support: Japan Science and Technology Agency