A Phase 2 interventional study of Oligo-fucoidan, Fucoxanthin, L-carnitine Formula, Zinc yeast (FFL) in Diabetic Kidney Disease (DKD), sponsored by Taipei Medical University WanFang Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Taipei Medical University WanFang Hospital · Phase 2, Interventional, and Treatment
Among 21 studies in Diabetic Nephropathies with a site in Taiwan — 3 open to participants now, 3 under way, none of them phase 3. Diabetic Nephropathies · Taiwan.
Among the 21 studies in Diabetic Nephropathies with a site in Taiwan, this one is the 14th largest by enrollment of the 17 interventional ones, is the only one that started in 2024, is one of 7 in phase 2, and was the 21st registered.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
This study's enrollment of 63 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →3 of the 21 studies in Diabetic Nephropathies with a site in Taiwan are open now, in 1 country. Each count lists the studies.
Of the 50 Diabetic Nephropathies studies recruiting now, 23 (46%) set no upper age limit and 16 (32%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2024.
Median enrollment 281 across the 17 interventional studies, 669 across the 4 observational. Of the 14 that completed or were terminated, 7 (50%) have results posted.
12 of 21 have an industry lead sponsor. The 10 most frequent:
Taipei Medical University WanFang Hospital is the lead sponsor of 201 studies on the registry; 20 are open to participants now.
Taipei Medical University WanFang Hospital has 1 study filed under Diabetic Nephropathies — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetic Nephropathies with a site in Taiwan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07657351China Medical University HospitalEffect of Chinese Herbal Medicine on Renal Function in Diabetic Kidney Disease | 2026-12-31 |
Among the 21 studies in Diabetic Nephropathies with a site in Taiwan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
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
Plan to share: 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.
Ran from Nov 2024 to primary completion in Nov 2025, 11 months.
Of 52 phase 2 interventional studies under Diabetic Nephropathies, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Taipei Medical University WanFang Hospital →