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

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. Trial registration The trial was registered on ClinicalTrials.gov. Identifier: NCT03811587. Registered 21th of January, 2019; retrospectively registered.

Integration of a fasting-mimicking diet program in primary care for type 2 diabetes reduces the need for medication – a 12-month randomised controlled trial

“…The Medical Research Ethics Committee of the LUMC approved the protocol and amendments. The study was registered as ClinicalTrials.gov NCT03811587, and the study protocol was published [17]. Registration of the trial was initiated prior to the start of the trial; online publication was however realized after the start of the trial due to delay within the registration process.…”

“…Ingredients were all plant-based and generally regarded as safe. Caloric content and macronutrient composition were as follows; day 1 contained ∼ 1100 kcal (10% protein, 56% fat and 34% complex carbohydrate); days 2–5 were identical and provided ∼ 3150 kJ (750 kcal, 9% protein, 44% fat, 47% complex carbohydrate) [17]. The diet of participants who weighed more than 100 kg was supplemented with one bar a day (90 kcal) with similar macronutrient composition.…”

Fasting: From Physiology to Pathology

“…[ 208 ] Similar results were also achieved by FMD. [ 209 ] Above all, because FMD is both effective and safe, it is a better treatment option for patients with T2DM. In addition, both TRF and IF can improve NAFLD.…”

Fasting: How to Guide

“…The most diverse evidence on fasting in humans included T2D patients who were treated with lifestyle advice only or also with a dose of metformin. However, T2D patients who use other types of anti-diabetic medication, especially insulin, might be at risk of developing hypoglycemia while using this medication in combination with the prolonged forms of fasting [ 134 ].…”