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

What Was Tested

This registered phase 2 trial tested L-Carnitine.

Participants were randomly assigned in a 1:1 ratio to either the Treatment Group or the Control Group.

It had two arms (groups): FFL group (experimental) and 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.

The registry classes the interventions as dietary supplement.

Who Took Part

63 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: age younger than 20 years; inability to understand or provide written informed consent; absence of regular treatment for diabetes mellitus.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

It started in 2024-11-06 with completion listed for 2025-11-05.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) (time frame: Baseline and Week 12). Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (time frame: Baseline and Week 12).

It also tracked 2 secondary outcomes, for example Percentage Change From Baseline in Glycated Hemoglobin (HbA1c) and Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 63 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.