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AzTrials

Diabetic Kidney Disease (DKD)Phase 2NCT07804641

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

A Phase 2 study testing Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL) in people with Diabetic Kidney Disease (DKD), run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diabetic Kidney Disease (DKD)
What is being tested?
Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteTaiwan
Study dates
6 Nov 2024to 11 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Wanfang Hospital, Taipei Medical Univeristy

    Taipei, 116

Other trials in Taiwan

About this study

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.

Being tested
Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL)
Keywords
Diabetic kidney disease, Oligo-fucoidan, Fucoxanthin, eGFR, Albuminuria
Medical subject headings
Diabetic Nephropathies, Albuminuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07804641
Study groupRoleWhat they receive
FFL groupExperimentalParticipants 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.
Receives: Dietary Supplement: Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL)
Control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and Week 12

  2. 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.

    Measured: Baseline and Week 12

Secondary outcomes (2)

  1. 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%.

    Measured: Baseline and Week 12

  2. 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%.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2026
  2. Study start6 Nov 2024
  3. Primary completion5 Nov 2025
  4. Study completion11 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07804641
Sponsor's protocol ID
N202409023
Status last verified
Aug 2026
First submitted
31 Aug 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data from this preliminary proof-of-concept trial will not be made publicly available to protect patient privacy and intellectual property confidentiality.

Publications

  • 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.

    PubMed 19491382

  • 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.

    PubMed 29920359

  • 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.

    PubMed 35215410

  • 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.

    PubMed 28098144

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL) in people with Diabetic Kidney Disease (DKD), run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07804641, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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