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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
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.
Wanfang Hospital, Taipei Medical Univeristy
Taipei, Taiwan
Percentage Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR)
The UACR was assessed via random spot urine collection. The primary outcome was expressed as the ratio of the difference (end-of-trial value minus baseline value) to the baseline value, calculated using the formula: \\((12-weekUACR-BaselineUACR)/BaselineUACR\\) \* 100%. A negative percentage indicates a reduction in albuminuria (improvement).
Time frame: Baseline and Week 12
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Serum creatinine was measured and eGFR was calculated using the 2021 CKD-EPI creatinine equation. The outcome was expressed as the ratio of the difference (end-of-trial value minus baseline value) to the baseline value, calculated using the formula: \\((12-weekeGFR-BaselineeGFR)/BaselineeGFR\\) \* 100%. This parameter was evaluated to monitor for any acute hemodynamically-induced decline (eGFR dip) upon treatment initiation.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Glycated Hemoglobin (HbA1c)
Blood samples were collected to analyze HbA1c levels for evaluating glycemic control. The outcome was expressed as the ratio of the difference (end-of-trial value minus baseline value) to the baseline value, calculated using the formula: \\((12-weekHbA1c-BaselineHbA1c)/BaselineHbA1c\\) \* 100%.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Fasting lipid profiles were analyzed to evaluate lipid metabolism. The outcome was expressed as the ratio of the difference (end-of-trial value minus baseline value) to the baseline value, calculated using the formula: \\((12-weekLDL-C-BaselineLDL-C)/BaselineLDL-C\\) \* 100%.
Time frame: Baseline and Week 12
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