Human randomized controlled trial

Effect of fasting-mimicking diet on markers of autophagy and metabolic health in human subjects

A pilot randomized trial in 30 healthy adults, measuring autophagy and metabolic markers in blood.

Geroscience, 2026. Espinoza SE, et al.

Funding and competing interests (as published with the paper): Declarations. Ethics approval and consent to participate: The study was approved by local institutional review boards at each participating institution and was conducted according to the principles of the Declaration of Helsinki. All participants provided written informed consent prior to enrolment. The trial was registered with ClinicalTrials.org (NCT06115551). Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Two of the twelve authors list L-Nutra, Prolon's parent company, as their affiliation.

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Study type
Human clinical trial (randomized, pilot, n=30)
Journal
Geroscience
Published
2026
Authors
Espinoza SE, et al.
DOI
10.1007/s11357-025-02035-4
PubMed ID
41372565

Summary

Thirty healthy participants, on average about 49 years old, were randomly assigned to one of two oral Fasting Mimicking Diet formulations or to a control condition for 8 days. Blood was collected at baseline, on days 4 and 6 of the intervention, and 48 hours after the diet finished. The authors measured autophagic flux in peripheral blood mononuclear cells, and also fasting plasma glucose, insulin, insulin-like growth factor 1, beta-hydroxybutyrate and a calculated index of insulin resistance.

The authors reported between-group differences in the change from baseline to the end of the 6-day dietary period for body weight, fasting glucose, beta-hydroxybutyrate, insulin resistance and autophagic flux. They also reported that those differences were not significant across all time points. They worded their conclusion as a possibility, saying the diet may improve autophagic flux and markers of metabolic health, and that larger samples are needed to extend the findings.

This is a pilot trial in thirty healthy adults over 8 days, which the authors themselves describe as too small to settle the question. The outcomes are laboratory markers measured in blood, not health outcomes, and the between-group differences were not consistent across the time points measured. Two different oral formulations were compared against a control, and the paper reports nothing about longer or repeated use.

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