Tokyo, May 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061656) titled 'Effects of consumption of the test food on subjective fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on May 22.

Study Type: Interventional

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

Primary Sponsor: Institute - Yotsuba Milk Products Co., Ltd.

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

Objective: Narrative objectives1 - To verify the reduction effects of consumption of the test food on temporary subjective fatigue in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Eight weeks Test product: Capsule containing Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take one capsule with water without chewing per day.

*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 Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take one capsule with water without chewing per day.

*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 subjective fatigue measured by visual analogue scale (VAS) increases after Uchida-Kraepelin test 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 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 drink to excess (average of more than about 20 g/day as pure alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}

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

14. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 13 Day Date of IRB - 2026 Year 05 Month 13 Day Anticipated trial start date - 2026 Year 05 Month 22 Day Last follow-up date - 2026 Year 09 Month 10 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070545

Disclaimer: Curated by HT Syndication.