Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059513) titled 'Effects of test food consumption on rating of perceived exertion and exercise motivation in healthy Japanese' on Oct. 22.

Study Type: Interventional

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

Primary Sponsor: Institute - Hamari Chemicals, Ltd.

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

Objective: Narrative objectives1 - To verify the effects of test food consumption on perceived exertion and exercise motivation in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Carnosine-containing food Administration: Consume two capsules containing a total of 200mg of carnosine 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: Placebo food Administration: Consume two hard capsules containing a placebo 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

Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged >= 18 and = 18.5 kg/m2 and = 15 at screening 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 symptoms such as hypoglycemia or anemia

8. Individuals who engage in training aimed at improving physical function (resistance training for increasing muscle mass, high-intensity aerobic exercise for enhancing cardiorespiratory function, or other training for participation in competitions or athletic events)

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

10. 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

11. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 40

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 23 Day Last follow-up date - 2026 Year 05 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068075

Disclaimer: Curated by HT Syndication.