Clinical Trial: The effects of test foods containing peptides on reducing fatigue in healthy adults: a randomized, double- blind, placebo-controlled, parallel-group, dose finding study (Japan)

Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061868) titled 'Dose-finding study of test foods containing peptides for reducing fatigue in healthy adults' on July 29.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyushu University

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of test foods containing peptides on subjective fatigue in healthy adults by comparing two different doses of test foods with a placebo Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of peptide-containing food (low dose) daily for 4 weeks Interventions/Control_2 - Intake of peptide-containing food (medium dose) daily for 4 weeks.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Individuals who are aware of experiencing fatigue in their daily life Individuals who have provided prior informed consent Key exclusion criteria - Individuals who are receiving treatment for chronic fatigue Individuals who are undergoing any medical treatment at a healthcare facility, including pharmacotherapy or treatment by a specialist Individuals with a current or past history of serious diseases Individuals who habitually consume pharmaceuticals, supplements, fortified foods, or vitamin products Individuals with a current or past history of drug or food allergies (including those who may develop allergic reactions to the test food) Individuals who participated in another clinical trial within one month prior to consent, are currently participating, or plan to participate during the study period Individuals who habitually consume excessive amounts of alcohol (equivalent to 60 g/day of alcohol) Individuals who smoke Individuals who engage in night-shift work Individuals deemed inappropriate for participation in this study by sub-investigator Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 28 Day Date of IRB - 2026 Year 05 Month 28 Day Anticipated trial start date - 2026 Year 07 Month 29 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070688

Disclaimer: Curated by HT Syndication.