Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055568) titled 'A verification study for the effects of DHA on human skeletal muscle function' on Sept. 18.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - ORTHOMEDICO Inc.

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

Objective: Narrative objectives1 - To verify the effects of DHA on human skeletal muscle function. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Eight weeks Test food: Fish sausage containing DHA Exercise intervention: Light exercise Interventions/Control_2 - Duration: Eight weeks Test food: Fish sausage containing DHA

Eligibility: Age-lower limit - 25 years-old = Gender - Male Key inclusion criteria - 1. Japanese

2. Men

3. Individuals aged between 25 and 45

4. Healthy individuals

5. Individuals whose average daily steps are 5000 or more in the seven days prior to screening (before intervention; Scr)

6. Individuals whose BMI are 25 kg/m2 or more and less than 30 kg/m2

7. Individuals whose triglyceride level is less than 150 mg/dL 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) and supplements

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

7. Individuals who have engaged in 30 minutes or more of exercise per day at least twice a week over the past year

8. Individuals who have consumed fish or fish-based processed foods (such as fish sausage) at least four days a week over the past year

9. 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

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

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 09 Month 11 Day Date of IRB - 2024 Year 09 Month 11 Day Anticipated trial start date - 2024 Year 09 Month 20 Day Last follow-up date - 2025 Year 02 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063491

Disclaimer: Curated by HT Syndication.