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Completed

NCT Number: NCT07804641

Safety and Efficacy of the Combination Therapy of Fucoidan / Fucoxanthin / L-carnitine in Patients With Diabetic Nephropathy.

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.

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Key information

Conditions

Diabetic Kidney Disease (DKD) Albuminuria Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wanfang Hospital, Taipei Medical Univeristy

Taipei, 116, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented glycated hemoglobin (HbA1c) > 6.5% with current use of anti-diabetic medication.
  • A urine albumin-to-creatinine ratio (UACR) greater than 30 mcg/mg.

Exclusion criteria

  • Age younger than 20 years.
  • Inability to understand or provide written informed consent.
  • Absence of regular treatment for diabetes mellitus.
  • Medication non-compliance, defined as completing less than 50% of the prescribed formula (FFL) treatment.
  • Newly diagnosed glomerulonephritis during the study period.
  • Loss to follow-up, defined as failure to complete all laboratory tests required for outcome assessment.

Treatment and study plan

Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL)

Dietary Supplement

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.

Primary outcomes

  1. Percentage Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR)

    Time frame: Baseline and Week 12

    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).

  2. Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline and Week 12

    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.

Secondary outcomes

  1. Percentage Change From Baseline in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline and Week 12

    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%.

  2. Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline and Week 12

    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%.

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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