Effect of Ingestion of the Test Food A and Test Food B on Body Composition: An Exploratory Study

UMIN ID: UMIN000054576

Registered date:06/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2024/06/07
• Target sample size: 240
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Non-ingestion
Daily ingestion of test food A for 16 weeks.
Daily ingestion of test food A and test food B for 16 weeks.

Outcome(s)

• Primary Outcome: Body composition (body weight, body fat rate, body mass index, muscle mass, lean body mass, Skeletal Muscle Mass, SMI, ECW/TBW) at 16 weeks after ingestion.
• Secondary Outcome: Physical fitness test, Vital signs, Blood inflammatory marker, Blood anti-oxidant markers, Blood lipids, Blood glucose, Questionnaire assessed frailty.

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who cannot perform activities of daily living on their own. 2. Subjects who cannot walk on their own and are restricted daily activities by physicians. 3. Subjects who are under physician's advice, treatment, and/or medication for quadriplegia, depression, dementia, neurological disease, amyotrophic lateral sclerosis. 4. Subjects with implantable electronic medical devices. 5. Subjects who are under treatment or have a history of serious diseases, or who affected with infectious diseases requiring reports to the authorities. 6. Subjects with major surgical history relevant to the digestive system. 7. Subjects who cannot ingestion test foods due to any reason, such as allergy. 8. Subjects who regularly take foods similar to test food A. 9. Subjects who regularly take foods similar to test food B. 10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 11. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study. 12. Subjects who currently participate in other clinical trials or participated within the last 4 wks prior to the current study. 13. Subjects who are ineligible due to physician's judgment.

Related Information

• Primary Sponsor: Hokkaido Information University
• Source(s) of Monetary Support: Meiji Holdings Co., Ltd.