Verification of the usefulness of food material intake for physical deterioration caused by aging

UMIN ID: UMIN000041066

Registered date:13/07/2020

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy
• Date of first enrollment: 2020/08/21
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

(1)Take test food once a day for 12 weeks (2) Participate in four exercise classes (3) Perform resistance exercise at home for 5 days a week
(1) Take placebo once a day for 12 weeks (2) Participate in four exercise classes (3) Perform resistance exercise at home for 5 days a week

Outcome(s)

• Primary Outcome: muscle function
• Secondary Outcome: Physical fitness indices, Muscle indices, Questionnaire about QOL and feelings

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects who meet the sarcopenia criteria (2) Subjects who take more protein than necessary (3) Subjects whose physical activity level is too high (4) Subjects who regularly use medicines that may affect muscle and lipid metabolism and amino acid preparations (5) Subjects who cannot stop taking supplements and health foods (including foods for specified health uses and foods with functional claims) (6) Screening test, subjects unable to quit drinking 2 days before each test (7) Subjects with a history of drug dependence or alcohol dependence or current medical history (8) Subjects who participated in tests that use other foods and pharmaceuticals, tests that apply cosmetics and pharmaceuticals, etc. within 1 month from the time of obtaining consent, and subjects who participate in other tests while participating in this study (9) Subjects with systolic blood pressure of 160 mmHg or more at screening test or diastolic blood pressure of 100 mmHg or more (10) Subjects suffering from serious kidney disease, digestive system disease, heart disease, respiratory system disease, endocrine disease or other metabolic diseases, or subjects under treatment (11) Subjects with physical disabilities such as severe low back pain and knee pain, which interfere with exercise (12) Subjects with a history of orthopedic surgery that interferes with movements such as the waist and knees (13) Subjects with metal implants such as pacemakers and bolts (14) Subjects with difficulty measuring muscle mass and muscle quality (15) Subjects whose exercise is prohibited by doctors (16) Subjects who are judged as unsuitable for the study by the investigators

Related Information

• Primary Sponsor: KSO Corporation
• Secondary Sponsor: KSO Corporation
• Source(s) of Monetary Support: Ajinomoto Co., Inc