Tokyo, April 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061228) titled 'Long-Term Safety Evaluation and Exploratory Assessment of Anti-Fatigue Effects of Continuous Intake of Food Containing Orotic Acid' on April 26.

Study Type: Interventional

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

Primary Sponsor: Institute - IMEQRD Co. Ltd.

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

Objective: Narrative objectives1 - To assess the safety of 12 weeks continuous intake of the investigational food in healthy men and women aged 20 to under 65, and to explore its potential effects on fatigue. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will take one tablet of the test food daily, allowing it to dissolve in the mouth without chewing. Interventions/Control_2 - Participants will take one tablet of the placebo food daily, allowing it to dissolve in the mouth without chewing.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1.Aged 20 to under 65 2.Japanese men and women 3.BMI less than 30.0 kg/m^2 4.Able to enter electronic diaries via smartphone or PC 5.Fully informed about the study and voluntarily consented electronically Key exclusion criteria - 1.Currently receiving treatment or medication (including Kampo) for any illness 2.Under dietary or exercise therapy supervised by a physician 3.Current or past serious illness 4.History of gastrointestinal surgery (except appendicitis) 5.Regular use of OTC drugs, quasi-drugs, health foods, supplements or foods with health claims; participation allowed if discontinued after consent 6.Current or past drug or food allergies 7.Habitual excessive alcohol intake (>=40g pure alcohol/day) 8.Habitual excessive smoking (>=21 cigarettes/day) 9.Shift workers with night shifts 10.Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study 11.Plans for overseas travel during the study 12.Pregnant, breastfeeding, or planning pregnancy during the study 13.Participation in other clinical trials, within one month prior to consent, currently participating, or plans to participate during the study 14.Deemed unsuitable by the principal or sub-investigator Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 17 Day Anticipated trial start date - 2026 Year 06 Month 11 Day Last follow-up date - 2026 Year 09 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070064

Disclaimer: Curated by HT Syndication.