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A verification study of the protection and improvement effects of the test food on kidney function

A verification study of the protection and improvement effects of the test food on kidney function: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the protection and improvement effects of the test food on kidney function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056313
Enrollment
76
Registered
2025-11-29
Start date
2024-11-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese

Interventions

Duration: 24 weeks Test food: Capsule containing DHA Duration: 24 weeks Test food: Capsule containing soybean oil

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. To verify the protection and improvement effects of kidney function

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026