Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062677) titled 'Effects of consumption of the test food on subjective fatigue in healthy Japanese' on Aug. 25.

Study Type: Interventional

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

Primary Sponsor: Institute - NOF CORPORATION

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

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on mood (subjective fatigue and inertia) in healthy Japanese Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Tablet containing rice bran extract Administration: Consume three tablets per day with water without chewing.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. Interventions/Control_2 - Duration: 12 weeks Test product: Tablet not containing rice bran extract Administration: Consume three tablets per day with water without chewing.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose T score of FI in POMS2 is high at Scr Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who are allergic to medications or foods related to the test product, particularly those who are allergic to rice

7. Individuals who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues

8. Individuals who have irregular sleeping time or habit due to work such as a late-night shift

9. Individuals who have irregular lifestyles (such as diet, exercise, and sleep)

10. Individuals who are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome

11. Individuals who work in physical labor such as transportation of heavy objects

12. Individuals who answered "there have been significant changes or events in life." on the medical questionnaire at Scr

13. Individuals who are pregnant, lactating, or planning pregnancy during this study

14. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 76

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 08 Month 06 Day Date of IRB - 2026 Year 08 Month 06 Day Anticipated trial start date - 2026 Year 08 Month 25 Day Last follow-up date - 2027 Year 02 Month 18 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071752

Disclaimer: Curated by HT Syndication.