Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062126) titled 'Effects of test food intake on physical function and muscle strength in middle-aged and older adults: a randomized, double-blind, placebo-controlled, parallel-group trial' on July 8.

Study Type: Interventional

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

Primary Sponsor: Institute - KSO Corporation

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

Objective: Narrative objectives1 - To evaluate the effect of 16-week intake of test food containing the active ingredient on physical function Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Daily intake of test food containing the active ingredient (high dose) for 16 weeks Interventions/Control_2 - Daily intake of test food containing the active ingredient (low dose) for 16 weeks

Eligibility: Age-lower limit - 50 years-old

Gender - Male and Female Key inclusion criteria - 1) Healthy men and women from 50 to 74 years old. 2) Individuals who subjectively feel that their physical fitness has declined compared with the past. 3) Individuals who have not engaged in regular exercise (at least 2 times per week and at least 30 minutes per session) for at least 1 year. 4) Individuals who have received a full explanation of the study objectives and procedures, have the capacity to provide informed consent, fully understand the study, voluntarily agree to participate, and have provided written informed consent. Key exclusion criteria - 1) Individuals with serious diseases such as diabetes, renal, hepatic, or cardiovascular diseases; thyroid or adrenal disorders; or other metabolic diseases, or those currently undergoing treatment for these conditions. 2) Individuals with chronic diseases who regularly use medications that may affect study outcomes. 3) Individuals who plan to start regular exercise (at least 2 times per week and at least 30 minutes per session) during the study period. 4) Individuals who have engaged in regular exercise (at least 2 times per week and at least 30 minutes per session) within the past 3 months. 5) Individuals who are unable to refrain from consuming supplements or health foods that may affect physical function or muscle strength during the study period. 6) Individuals who are unable to refrain from consuming foods rich in lactic acid bacteria, bifidobacteria, oligosaccharides, or live microorganisms during the study period. 7) Individuals who are expected to require regular medical visits or use of prescribed medications each year due to pollinosis or allergic rhinitis. 8) Individuals with implanted medical devices such as pacemakers or implantable cardioverter-defibrillators, or with metal implants in the body. 9) Individuals with allergies to medications or study food-related products. 10) Individuals with gastrointestinal diseases or a history of gastrointestinal surgery that may affect digestion or absorption (excluding appendicitis). 11) Individuals with a body mass index (BMI) of 30 or higher. 12) Night shift workers or individuals engaged in late-night work. 13) Individuals with a current or past history of drug or alcohol dependence. 14) Individuals currently participating in, or planning to participate in, other clinical studies involving the ingestion of foods, use of medications, or application of cosmetics or pharmaceuticals.

Due to character limitations, part of the exclusion criteria is presented in the "Other relevant information" section. Target Size - 180

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 11 Day Date of IRB - 2026 Year 06 Month 11 Day Anticipated trial start date - 2026 Year 08 Month 12 Day Last follow-up date - 2027 Year 01 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071066

Disclaimer: Curated by HT Syndication.