Tokyo, Nov. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056313) titled 'A verification study of the protection and improvement effects of the test food on kidney function' on Nov. 29.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are 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 protection and improvement effects of the test food on kidney function Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Duration: 24 weeks Test food: Capsule containing DHA Interventions/Control_2 - Duration: 24 weeks Test food: Capsule containing soybean oil

Eligibility: Age-lower limit - 45 years-old = Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged between 45 and 75

4. Healthy individuals

5. Individuals whose values of estimated glomerular filtration rate creatinine (eGFRcreat) are within the range of 45 =< eGFR < 90 Key exclusion criteria - Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. 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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. are taking or using medications (including herbal medicines) and supplements

6. are allergic to medicines and foods related to the test product, particularly who show allergic reactions to seafood, soybeans, peanuts

7. are pregnant, lactating, or planning to become pregnant during this study

8. 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

9. usually take medicines (diuretics, antihypertensive agents, sodium glucose cotransporter 2 (SGLT2) inhibitors, warfarin, uricosuric agents, or others), dietary supplements (claiming lowering effects of triglyceride, blood pressure, or blood glucose, or related to urination), or others which may influence the results of this study

10. have a past or current medical history of the following diseases: severe liver disorder, kidney disorder, heart disease, hepatitis, extreme anemia, alcohol dependency, hemorrhagic disease (hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract bleeding, hemoptysis, vitreous bleeding, or others)

11. require assistance, or have difficulty to walk independently

12. have seafood and fish roe at least 4 days per week

13. are judged as ineligible to participate in this study by the physician Target Size - 76

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 11 Month 12 Day Date of IRB - 2024 Year 11 Month 12 Day Anticipated trial start date - 2024 Year 11 Month 29 Day Last follow-up date - 2025 Year 10 Month 14 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064346

Disclaimer: Curated by HT Syndication.