Human randomized controlled trial

An Intermittent Fasting Mimicking Nutrition Bar Extends Physiologic Ketosis in Time Restricted Eating: A Randomized, Controlled, Parallel-Arm Study

Nutrients, 2021. Huang AW, et al.

Funding and competing interests (as published with the paper): The study foods were manufactured by L-Nutra, Inc. J.A. and W.C.H. are the CEO and the Chief Medical Officer of L-Nutra, respectively; and they have equity interest in L-Nutra. A.W.H., M.W. and S.C. are employee and consultant at L-Nutra.

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Study type
Human clinical trial (randomized, product-specific)
Journal
Nutrients
Published
2021
Authors
Huang AW, et al.
DOI
10.3390/nu13051523
PubMed ID
33946428

Summary

In this randomized, controlled trial, researchers compared a 200-calorie Fasting Mimicking Diet (FMD) energy bar, eaten after an overnight fast, against continuing a water-only fast and against a breakfast control group, measuring blood ketone (beta-hydroxybutyrate) and glucose levels over the following hours.

The authors reported that the FMD bar group's ketone levels at 3 and 4 hours after eating were non-inferior to (not meaningfully lower than) the water-fasting group, and that the blood glucose response was also non-inferior between the two groups, which the authors interpret as the bar not interfering with the ketosis that follows an overnight fast.

This is a human trial testing a specific FMD-formulated bar against a water fast over a single short window, measuring only ketone and glucose markers; it does not report on longer-term health outcomes, weight, or disease risk.

A randomized trial of a single bar eaten after an overnight fast. The study foods were made by L-Nutra, and several authors work for or consult for L-Nutra.

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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