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Safety and Efficacy of the Combination Therapy of Fucoidan / Fucoxanthin / L-carnitine in Patients With Diabetic Nephropathy.
Sponsor: Taipei Medical University WanFang Hospital
Summary
The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of The purpose of this open-label, preliminary, proof-of-concept clinical trial is to evaluate the efficacy and safety of fucoidan/fucoxanthin/L-carnitine combinaed therapy in patients with diabetic kidney disease. Participants were randomly assigned in a 1:1 ratio to either the Treatment Group or the Control Group. The primary objective is to investigate whether fucoidan/fucoxanthin/L-carnitine/Zinc yeast combinaed therapy can significantly improve albuminuria or renal function after a treatment period of 12 weeks. Secondary outcomes include evaluating the safety profile and potential side effects of the intervention. It is hypothesized that the intervention will show a beneficial effect on albuminuria compared to the control group. in patients withdiabetic kidney disease.
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2024-11-06
Completion Date
2026-03-11
Last Updated
2026-09-04
Healthy Volunteers
No
Conditions
Interventions
Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL)
Combined marine-derived formulation administered orally in capsule form. Each day, participants took 4 capsules, providing a total daily dose of 740 mg of low-molecular-weight oligo-fucoidan, 1200 mg of fucoxanthin-containing extract, and 120 mg of L-carnitine. The intervention was used as an add-on therapy to standard diabetic kidney disease care for a total duration of 12 weeks.
Locations (1)
Wanfang Hospital, Taipei Medical Univeristy
Taipei, Taiwan