Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059470) titled 'Effects of consumption of the test food on mood (fatigue and inertia) in healthy Japanese' on Oct. 20.

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 (fatigue and inertia) in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Eight weeks Test product: Capsule containing rice bran extract Administration: Take two capsules per day with water without chewing.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. Interventions/Control_2 - Duration: Eight weeks Test product: Capsule not containing rice bran extract Administration: Take two capsules per day with water without chewing.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next 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 VA in POMS2 is less than 60 at screening (Scr)

6. Individuals who met the inclusion criteria 1~5 and have high T score of FI in POMS2 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 medicines (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product

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 that there had been major changes or events in their life at questionnaire of Scr

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

14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

15. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 38

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 08 Day Date of IRB - 2025 Year 10 Month 08 Day Anticipated trial start date - 2025 Year 10 Month 20 Day Last follow-up date - 2026 Year 03 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068016

Disclaimer: Curated by HT Syndication.