Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055916) titled 'A confirmation study for the effects of consumption of the test food on blood amino acid levels' on Nov. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - ORTHOMEDICO Inc.

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

Objective: Narrative objectives1 - To compare and verify the blood amino acid dynamics after consumption of new fish protein material in comparison with milk protein. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Single ingestion Test food A Interventions/Control_2 - Duration: Single ingestion Test food B

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - 1. Japanese

2. Men

3. Individuals aged 20 or more and less than 40

4. Healthy individuals

5. Individuals whose BMI are less than 30 kg/m2 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, particularly those allergic to fish or milk

7. Individuals whose lifestyles are irregular due to working a late-night shift or others

8. Individuals who have food allergies and/or food intolerances

9. Individuals who have developed abdominal pain or gastrointestinal symptoms due to consuming high-protein foods

10. Individuals who have or are undergoing medical treatment for diseases which influence digestion and absorption of nutrients

11. Individuals who are taking steroids, protease inhibitors, or antipsychotics

12. Individuals who are smokers

13. Individuals who cannot take test foods

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 - 24

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 10 Month 16 Day Date of IRB - 2024 Year 10 Month 16 Day Anticipated trial start date - 2024 Year 10 Month 22 Day Last follow-up date - 2024 Year 12 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063890

Disclaimer: Curated by HT Syndication.