Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes

Conditions

Diabetes Mellitus, Type 2

Keywords

Diet, Fasting

Brief summary

In this randomized, controlled, assessor blinded and prospective intervention study the investigators will evaluate the clinical feasibility and effectiveness of intermittent use of a fasting mimicking diet in patients with type 2 diabetes mellitus compared to usual care.

Detailed description

100 individuals (men or women, ethnicity not specified) with type 2 diabetes and a BMI≥ 27, who are treated with diet only and have a HbA1c \> 48, or who are treated with diet and a dose of metformin can participate in the study. Participants will use a fasting-mimicking diet for 5 consecutive days per month. For the other days, there are no regulations. During follow-up of one year, several study parameters will be measured including HbA1c and antidiabetic medication dosage.

Chen R, Westenberg JJM, van den Burg EL, Schoonakker MP, le Cessie S, van Peet PG, Pijl H, Lamb HJ.

2026-08-01

10.1148/ryct.250547

Cost-effectiveness of a periodic fasting-mimicking diet programme in patients with type 2 diabetes: a trial-based analysis and a lifetime model-based analysis

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A fasting-mimicking diet programme reduces abdominal adipose tissue while preserving abdominal muscle mass in persons with type 2 diabetes

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10.1016/j.numecd.2025.104111

A fasting-mimicking diet programme reduces liver fat and liver inflammation/fibrosis measured by magnetic resonance imaging in patients with type 2 diabetes.

van den Burg EL, Schoonakker MP, van Peet PG, le Cessie S, Numans ME, Pijl H, Lamb HJ.

2025-02-184 citations

10.1016/j.clnu.2025.02.017

Fasting-mimicking diet in type 2 diabetes reduces myocardial triglyceride content: A 12-month randomised controlled trial

Paul R. Roos, Elske L. van den Burg, Marjolein P. Schoonakker, Petra G. van Peet, Mattijs E. Numans et al. (8 authors)

Nutrition Metabolism and Cardiovascular Diseases2025-01-092 citations

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Self-initiated lifestyle changes during a fasting-mimicking diet programme in patients with type 2 diabetes: a mixed-methods study.

van den Burg EL, Schoonakker MP, Korpershoek B, Sommeling LE, Sturm CA, Lamb HJ, Pijl H, Numans ME, Adriaanse MA, van Peet PG.

2024-05-026 citations

10.1186/s12875-024-02405-5

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.

van den Burg EL, Schoonakker MP, van Peet PG, van den Akker-van Marle EM, Lamb HJ, Longo VD, Numans ME, Pijl H.

2024-03-2817 citations

10.1007/s00125-024-06137-0

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 Burg, Marjolein P. Schoonakker, Petra G. van Peet, M. Elske van den Akker‐van Marle, Ko Willems van Dijk et al. (9 authors)

BMC Endocrine Disorders2020-06-2424 citations

10.1186/s12902-020-00576-7

Interventions

OTHERFasting Mimicking diet

The fasting mimicking diet is though to activate the metabolism as fasting would do, although the diet does include several meals a day and more calories than conventional fasting diets.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Only measurements by assessors will be blinded.

Intervention model description

Patients will be randomised to the intervention or control group.

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

No

Inclusion criteria

* Diagnosis of type 2 diabetes * Age \> 17 years and \<75 years * Treatment with diet only and have a HbA1c \> 48, or treatment with diet and metformin * BMI ≥ 27

Exclusion criteria

* Recent myocardial infarction (\< 6 months) * Creatinine clearance \< 30 ml/min/1,73m2 (MDRD) * Pregnancy * Contraindications for MRI * Allergy for nuts, sesame, soya or another ingredient of the diet * History of syncope with calorie restriction in the past * Any significant other disease (at the discretion of the investigator)

Design outcomes

Primary

Measure	Time frame
Concentration of HbA1c	12 months
Dosage of antidiabetic medication used	12 months

Countries

Netherlands

Outcome results

None listed