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

NCT07804641 | Completed Phase 2 DMC

• 1 other identifier: N202409023
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Kidney Disease (DKD)

Keywords

Diabetic kidney disease; Oligo-fucoidan; Fucoxanthin; eGFR; Albuminuria

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline and Week 12

Secondary Outcomes (2)

• Percentage Change From Baseline in Glycated Hemoglobin (HbA1c)

  Baseline and Week 12

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

  Baseline and Week 12

Study Arms (2)

FFL group

EXPERIMENTAL

Participants received the marine-derived formula FFL (a combination of low-molecular-weight oligo-fucoidan, fucoxanthin-containing extract, and L-carnitine) as an adjunctive therapy to their existing standard-of-care for diabetic kidney disease. The daily dose consisted of 4 capsules per day, delivering a total of 740 mg of oligo-fucoidan, 1200 mg of fucoxanthin, and 120 mg of L-carnitine. The intervention was maintained for a total duration of 12 weeks while keeping their baseline anti-diabetic and renoprotective medications unchanged.

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

Control group

NO INTERVENTION

Participants continued their optimized standard-of-care treatment for diabetic kidney disease (including SGLT2 inhibitors and ACEIs/ARBs) for 12 weeks. No active capsules or placebos were administered to this group. All baseline anti-diabetic and blood pressure medications were required to remain stable and unchanged throughout the study period.

Interventions

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.

FFL group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Wanfang Hospital, Taipei Medical Univeristy

Taipei, 116, Taiwan

Location

Related Publications (4)

• Chen HH, Sue YM, Chen CH, Hsu YH, Hou CC, Cheng CY, Lin SL, Tsai WL, Chen TW, Chen TH. Peroxisome proliferator-activated receptor alpha plays a crucial role in L-carnitine anti-apoptosis effect in renal tubular cells. Nephrol Dial Transplant. 2009 Oct;24(10):3042-9. doi: 10.1093/ndt/gfp258. Epub 2009 Jun 2.

  PMID: 19491382 BACKGROUND

• Chen YC, Cheng CY, Liu CT, Sue YM, Chen TH, Hsu YH, Hwang PA, Chen CH. Alleviative effect of fucoxanthin-containing extract from brown seaweed Laminaria japonica on renal tubular cell apoptosis through upregulating Na+/H+ exchanger NHE1 in chronic kidney disease mice. J Ethnopharmacol. 2018 Oct 5;224:391-399. doi: 10.1016/j.jep.2018.06.023. Epub 2018 Jun 18.

  PMID: 29920359 BACKGROUND

• Chen TH, Liu CT, Cheng CY, Sue YM, Huang NJ, Chen CH. Oligosaccharides Ameliorate Acute Kidney Injury by Alleviating Cluster of Differentiation 44-Mediated Immune Responses in Renal Tubular Cells. Nutrients. 2022 Feb 11;14(4):760. doi: 10.3390/nu14040760.

  PMID: 35215410 BACKGROUND

• Chen CH, Sue YM, Cheng CY, Chen YC, Liu CT, Hsu YH, Hwang PA, Huang NJ, Chen TH. Oligo-fucoidan prevents renal tubulointerstitial fibrosis by inhibiting the CD44 signal pathway. Sci Rep. 2017 Jan 18;7:40183. doi: 10.1038/srep40183.

  PMID: 28098144 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Albuminuria

Interventions

fucoxanthin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chief Physician

Model Details: This is a randomized, open-label, parallel-group trial with a 1:1 allocation ratio. Eligible participants were assigned to either the FFL group or the control group. Both groups maintained their optimized standard-of-care treatments for diabetic kidney disease (including SGLT2 inhibitors and ACEIs/ARBs) unchanged throughout the entire 12-week study period.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: November 6, 2024
• Primary Completion: November 5, 2025
• Study Completion: March 11, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)