Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056743) titled 'The effect of beta-hydroxybutyrate (D-BHB)-containing protein intake on physical and mental fatigue in healthy adult' on Feb. 28.

Study Type: Interventional

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

Primary Sponsor: Institute - User Life Science Co., Ltd.

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

Objective: Narrative objectives1 - To investigate the effect of beta-hydroxybutyrate (D-BHB) intake on physical and mental health in healthy adult Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - To dissolve D-BHB-containing protein (D-BHB 2 g/day) in 200 ml of water and intake it for 4 weeks (28 days) Interventions/Control_2 - To dissolve the placebo protein not containing D-BHB in 200 ml of water and intake it for 4 weeks (28 days)

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) persons who is generally judged as healthy (2) Persons who can give voluntary written consent to participate in the present trial (3) Persons who are aware of their physical and mental fatigue and stress Key exclusion criteria - (1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2) persons who have changed their habitats to take supplements within past 4 weeks. (3) Persons who work in night shift or in day and night shift (4) persons who have been treated their illness or prevention in a clinic at their informed consent (5) persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) persons with the medical histories of alcoholism or drug dependence (7) persons who might be developed allergic reaction to foods (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10) persons who will not be judged suitable to the participants by the investigator Target Size - 40

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 12 Month 20 Day Date of IRB - 2024 Year 03 Month 06 Day Anticipated trial start date - 2025 Year 01 Month 17 Day Last follow-up date - 2025 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064847

Disclaimer: Curated by HT Syndication.