Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062315) titled 'Exploratory study on the effects of attributes, lifestyle, and dietary habits on body composition in middle-aged and older adults' on July 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Hokkaido Information University

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To explore the effects of demographic characteristics, lifestyle, and dietary habits on changes in body composition during a 12-week dietary intervention involving foods containing GABA, isoflavones, and Beta-cryptoxanthin, using an open-label, uncontrolled trial. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Foods containing GABA, isoflavones, and Beta-cryptoxanthin

Eligibility: Age-lower limit - 55 years-old

Gender - Male and Female Key inclusion criteria - Those who agree to participate in this study with a written informed consent Japanese men and women aged 55 to 64 at the time of the screening examination (preliminary examination) Those who are aware of muscle weakness Those with a relatively low skeletal muscle index Key exclusion criteria - Those receiving nutritional guidance as part of medical treatment. Those receiving continuous medication affecting bone metabolism. Those diagnosed with diabetes mellitus. Those with an HbA1c level >= 6.5% at screening. Those diagnosed with dyslipidemia. Those with LDL-C levels >= 180 mg/dL at screening. Those with eGFR levels = 35 kg/m^2 at screening. Those with severe cerebrovascular, cardiac, hepatic, renal, gastrointestinal, respiratory, or notifiable infectious diseases. Those using medications/supplements affecting blood pressure (e.g., monoglucosyl hesperidin, lactotripeptides). Those routinely using health foods/supplements with GABA. Those routinely using health foods/supplements with beta-cryptoxanthin. Those routinely using health foods/supplements with soy isoflavones. Those whose soy isoflavone intake may exceed the safe limit (70-75mg/day) due to the test food. Those with major abnormalities in blood pressure, anthropometry, or blood tests. Those with potential allergies to drugs or foods (especially soy). Those unable to continuously consume the test food due to allergic reactions etc. Those with a history of feeling unwell or sick due to blood collection. Those with implanted metal devices (pacemakers, ICDs, artificial joints, plates, etc.). Those with metal implants in the lumbar spine or hip joints. Those expecting major daily lifestyle changes during the study. Perimenopausal women experiencing significant physical changes. Heavy smokers, heavy drinkers, or those with extremely irregular lifestyles. Those who donated 400mL blood within 16 (women)/12 (men) weeks, 200mL within 4 weeks, or components within 2 weeks before intake. Those in other clinical trials, observational studies, or home-use tests from 4 weeks before screening to completion. Any others deemed ineligible by the principal investigator. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 29 Day Date of IRB - 2026 Year 06 Month 29 Day Anticipated trial start date - 2026 Year 08 Month 04 Day Last follow-up date - 2027 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071242

Disclaimer: Curated by HT Syndication.