Tokyo, July 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062105) titled 'Exploratory study on the effects of oligosaccharide intake on frailty indicators' on July 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Meiji Co., Ltd.

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

Objective: Narrative objectives1 - This randomized, placebo-controlled, double-blind, parallel-group exploratory study will enroll 100 healthy adults aged 65 years or older (50 participants in the test-food group and 50 participants in the control-food group) to evaluate the effects of continuous 24-week intake of oligosaccharides, a prebiotic, on the gut microbiota and frailty indicators. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Oral intake of an oligosaccharide-containing food for 24 weeks Interventions/Control_2 - Oral intake of a food in which oligosaccharide is replaced with dextrin for 24 weeks

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Healthy Japanese men and women aged 65 years or older at the time of informed consent 2. Individuals who are aware of decreased muscle strength or reduced muscle mass 3. Individuals who have received sufficient explanation of the purpose and content of the study, have the capacity to provide consent, have adequately understood the study, and voluntarily agree to participate of their own free will Key exclusion criteria - Subjects who meet any of the following criteria: - Subjects with severe or progressive diseases (including hepatic impairment, renal or cardiac disease, pulmonary or gastrointestinal disorders, diabetes, rheumatoid arthritis, neurological or psychiatric disorders, etc.) - Subjects with musculoskeletal disorders (including sarcopenia) or impaired walking ability - Subjects with a history of gastrointestinal surgery that may affect the study outcomes - Subjects who have undergone barium examination or intestinal cleansing (including colonoscopy) within 1 month prior to screening, or who plan to undergo such procedures during the study period - Subjects currently undergoing diet or exercise therapy under medical supervision - Subjects using medications that may affect the study outcomes (e.g., antibiotics, gastric acid suppressants, laxatives) or who plan to use them during the study period - Subjects who regularly consume dietary supplements or foods for specified health uses that may affect the study outcomes and are unable to discontinue them during the study period - Subjects with food allergies - Subjects with excessive smoking (21 cigarettes/day or more) or alcohol consumption (40 g of ethanol/day or more) - Subjects with irregular lifestyles due to shift work or night work - Subjects with excessive exercise habits (e.g., resistance training 4 times/week or more) - Subjects planning major lifestyle changes or long-term travel (including overseas travel or trips exceeding 1 week) during the study period - Subjects with implanted medical devices (e.g., metal implants, pacemakers) or with a history of electrocardiogram abnormalities - Subjects who have participated in other clinical studies within 1 month prior to consent, are currently participating, or plan to participate during the study period - Subjects deemed inappropriate for participation by the principal investigator or sub-investigators Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 29 Day Date of IRB - 2026 Year 05 Month 29 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2027 Year 04 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071053

Disclaimer: Curated by HT Syndication.