Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention tr
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Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes Elske L. van den Burg1* , Marjolein P. Schoonakker1, Petra G. van Peet1, M. Elske. van den Akker-van Marle2, Ko Willems van Dijk3,4, Valter D. Longo5,6, Hildo J. Lamb7, Mattijs E. Numans1 and Hanno Pijl3
Abstract Background: Caloric restriction is an effective way to treat Type 2 diabetes (T2D). However, chronic and severe restriction of food intake is difficult to sustain and is known to promote slower metabolism. Intermittent and frequent fasting can exert similar metabolic effects, but may be even more challenging for most patients. A fasting-mimicking diet (FMD) is low in calories, sugars and proteins, but includes relatively high levels of plant based complex carbohydrates and healthy fats. The metabolic effects of such a diet mimic the benefits of water-only fasting. The effects of a FMD applied periodically in T2D patients are still unknown. The Fasting In diabetes Treatment (FIT) trial was designed to determine the effect of intermittent use (5 consecutive days a month during a year) of a FMD in T2D patients on metabolic parameters and T2D medication use compared to usual care. Methods: One hundred T2D patients from general practices in the Netherlands with a BMI ≥ 27 kg/m2, treated with lifestyle advice only or lifestyle advice plus metformin, will be randomised to receive the FMD plus usual care or usual care only. Primary outcomes are HbA1c and T2D medication dosage. Secondary outcomes are anthropometrics, blood pressure, plasma lipid profiles, quality of life, treatment satisfaction, metabolomics, microbiome composition, MRI data including cardiac function, fat distribution and ectopic fat storage, cost-effectiveness, and feasibility in clinical practice. Discussion: This study will establish whether monthly 5-day cycles of a FMD during a year improve metabolic parameters and/or reduce the need for medication in T2D. Furthermore, additional health benefits and the feasibility in clinical practice will be measured and a cost-effectiveness evaluation will be performed. (Continued on next page)
* Correspondence: [email protected] 1 Department of Public Health and Primary Care, Leiden University Medical Center (LUMC), Postzone V0-P, Postbus 9600, 2300 RC, Leiden, The Netherlands Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated oth
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