Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059194) titled 'Evaluation of the efficacy and safety of test foods for older adults' on March 31.

Study Type: Interventional

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

Primary Sponsor: Institute - Morinaga & Co., Ltd.

Condition: Condition - N/A Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to assess the effectiveness and safety of the test food. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Oral intake of the test food for 48 weeks with an exercise intervention Interventions/Control_2 - Oral intake of the placebo food for 48 weeks with an exercise intervention

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - 1) Males or females aged 50-79 years who had provided informed consent. 2) Ability to perform the physical activities required for the conduct of the study. 3) Ability to provide their own smartphone and email address, and to download and use the program/app necessary for the study on that smartphone. 4) Ability to understand the study purpose and procedures, and participate voluntarily. Key exclusion criteria - 1)A total HDS-R score of 20 or less at screening. 2)Difficulty with color discrimination or other problems that interfere with cognitive testing. 3)Unable to complete web questionnaires. 4)Current, prior, or suspected dementia, psychiatric, neurological, or cerebrovascular disease. 5)Current menopausal disorder. 6)Taking medications that could affect the study results. 7)Have undergone cognitive testing within 3 months before screening, or plan non-study cognitive testing during the study. 8)Having a disorder affecting motor function and currently receiving pharmacological treatment. 9)Regularly engaging in activities that influence motor function. 10)Absolute contraindication to exercise therapy or exercise stress testing. 11)Unable to perform measurements or exercise due to injury or illness. 12)Engage regularly in moderate-to-vigorous exercise totaling 3 hours or more per week. 13)Planned unavoidable intense exercise during the study. 14)Have major surgery planned during the study or are awaiting major surgery. 15)Current or past serious illnesses (e.g., malignant neoplasm, diabetes, liver, kidney, or heart disease). 16)Are at risk of developing an allergy related to the study. 17)Regularly using dietary supplements or medications containing the study's active ingredient. 18)Regularly consuming supplements intended to affect cognition, motor, or immune function. 19)Will have multiple occurrences of irregular lifestyle during the study. 20)Plan to change lifestyle habits during the study unrelated to participation in this study. 21)Regular heavy alcohol consumption. 22)Smoke 21 or more cigarettes per day. 23)Participation in another clinical trial within 1 month before consent, or planned during the study. 24)Pregnant or breastfeeding, or plan pregnancy during the study. 25)Judged unsuitable as a study subject based on responses to questionnaire or screening. 26)Any other reason the principal investigator considers the candidate unsuitable for participation. Target Size - 52

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 18 Day Date of IRB - 2025 Year 09 Month 25 Day Anticipated trial start date - 2025 Year 09 Month 26 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067681

Disclaimer: Curated by HT Syndication.