Human randomized controlled trial

Integration of a fasting-mimicking diet programme in primary care for type 2 diabetes reduces the need for medication and improves glycaemic control: a 12-month randomised controlled trial

A randomized trial in adults with type 2 diabetes, in which the FMD was added to their usual primary care.

Diabetologia, 2024. van den Burg EL, et al.

Funding and competing interests (as published with the paper): The project was co-funded by Health~Holland, Top Sector Life Sciences & Health, the Dutch Diabetes Foundation and L-Nutra. Competing-interests statement: see the published paper.

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Study type
Human clinical trial (randomized, assessor-blinded, n=100)
Journal
Diabetologia
Published
2024
Authors
van den Burg EL, et al.
DOI
10.1007/s00125-024-06137-0
PubMed ID
38546821

Summary

One hundred adults with type 2 diabetes managed with metformin and/or diet, under their regular primary care doctor, were randomly assigned over 12 months to add monthly 5-day Fasting Mimicking Diet (FMD) cycles to usual care, or to continue usual care alone, in this assessor-blinded trial.

The authors reported that after 12 months, the FMD group needed less glucose-lowering medication, had improved HbA1c despite using less medication, and lost more body weight than the usual-care group; on the authors' combined measure of glycaemic management (medication use and HbA1c together), 53% of the FMD group improved compared with 8% of the usual-care group, and 23% versus 59% deteriorated.

This was a real-world primary-care trial in people already diagnosed with type 2 diabetes and already on treatment; it reports change in medication use and blood sugar control in that specific population, not a claim about preventing or curing diabetes. The FMD was added to participants' regular care from their general practitioner, not used in place of it. The study was co-funded in part by L-Nutra, Prolon's parent company.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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