Tokyo, Dec. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060089) titled 'Evaluation of the effects of test foods on motor function' on Dec. 20.

Study Type: Interventional

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

Primary Sponsor: Institute - Rohto Pharmaceutical Co.,Ltd.

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

Objective: Narrative objectives1 - To evaluate the efficacy of the test food in improving motor function and its safety during 12 weeks of continuous intake. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Supplementation of the test food over a period of 12 weeks

Eligibility: Age-lower limit - 18 years-old < Age-upper limit - Not applicable Gender - Male Key inclusion criteria - (1) Healthy males from 18 years or older at the time of consent. (2) Person who can understand the purpose and content of this study and agree in this study. Key exclusion criteria - (1) Subjects who are unable to ingest the study food (supplement) or who have allergies to any of its ingredients. (2) Subjects who are currently receiving medical treatment-such as outpatient care or medication-or who are judged by the study-site physician to have a significant medical history requiring exclusion. (3) Subjects who have repeatedly experienced discomfort or adverse physical reactions during past blood draws. (4) Subjects who have donated blood components or donated 200 mL or more of whole blood within one month prior to the initial examination date, or who plan to do so during the study period. (5) Subjects who are currently participating in another clinical trial, or who participated in another clinical trial within two months prior to the initial examination date. (6) Subjects who regularly use pharmaceuticals, quasi-pharmaceuticals, Kampo medicines, or health foods (including supplements, over-the-counter drugs,Foods for Specified Health Uses, and foods with functional claims) that may influence the study, or who have continuously consumed health foods likely to affect body composition or muscle function within the three months prior to providing consent. (7) Subjects with markedly irregular dietary habits or lifestyles that may substantially influence the study results. (8) Subjects who are judged unsuitable as study participants based on the results of preliminary examinations or lifestyle questionnaires. (9) Subjects who are otherwise judged unsuitable for participation in this study by the principal investigator or the study-site physician. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 18 Day Date of IRB - 2025 Year 12 Month 18 Day Anticipated trial start date - 2025 Year 12 Month 22 Day Last follow-up date - 2026 Year 04 Month 10 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068720

Disclaimer: Curated by HT Syndication.