Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058850) titled 'A study to verify the effects of consuming fish sausage containing refined fish oil on skeletal muscle mass and muscle endurance' on Aug. 20.

Study Type: Interventional

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

Primary Sponsor: Institute - Maruha Nichiro Corporation

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

Objective: Narrative objectives1 - To verify the effects of consuming fish sausage containing refined fish oil on skeletal muscle mass and muscle endurance Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Intervention: Fish sausage containing refined fish oil + exercise Interventions/Control_2 - Duration: 12 weeks Intervention: Fish sausage containing palm oil + exercise

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 step count is 5,000 or more in the 7 days prior to screening

6. Individuals whose BMI is 23 kg/m2 or higher at screening

7. Individuals whose body fat percentage is 20% or higher 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 disease

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 (seafood, wheat, soybeans, gelatin)

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 (such as mackerel, sardines, and horse mackerel, as well as tuna, bonito, cod, salmon, and trout) or fish-based processed foods (such as fish sausage) at least four days a week over the past year

9. Individuals who are smokers/quit smoking within a year before agreeing to participate

10. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate 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 - 72

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 08 Month 06 Day Date of IRB - 2025 Year 08 Month 06 Day Anticipated trial start date - 2025 Year 08 Month 20 Day Last follow-up date - 2026 Year 03 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067291

Disclaimer: Curated by HT Syndication.