Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Nov 2018
Typical duration for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2018
CompletedFirst Submitted
Initial submission to the registry
January 13, 2019
CompletedFirst Posted
Study publicly available on registry
January 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2021
CompletedApril 7, 2022
April 1, 2022
2.8 years
January 13, 2019
April 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Concentration of HbA1c
12 months
Dosage of antidiabetic medication used
12 months
Study Arms (2)
Treatment group
EXPERIMENTALDiabetes type 2 patients will take a fasting mimicking diet of 5 consecutive days a month, for a duration of 12 months. Besides this, they will receive usual diabetes care from the general practitioner.
Control group
NO INTERVENTIONDiabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden University Medical Centerlead
- Dutch Diabetes Research Foundationcollaborator
- Health Hollandcollaborator
- IFOM ETS - The AIRC Institute of Molecular Oncologycollaborator
- L-Nutracollaborator
Study Sites (1)
Leiden University Medical Centre
Leiden, South Holland, Netherlands
Related Publications (6)
Schoonakker MP, van den Burg EL, van Peet PG, le Cessie S, Penny E, Numans ME, Pijl H, Lamb HJ. A fasting-mimicking diet programme reduces abdominal adipose tissue while preserving abdominal muscle mass in persons with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2025 Oct;35(10):104111. doi: 10.1016/j.numecd.2025.104111. Epub 2025 Apr 30.
PMID: 40425403DERIVEDvan den Burg EL, Schoonakker MP, van Peet PG, le Cessie S, Numans ME, Pijl H, Lamb HJ. A fasting-mimicking diet programme reduces liver fat and liver inflammation/fibrosis measured by magnetic resonance imaging in patients with type 2 diabetes. Clin Nutr. 2025 Apr;47:136-145. doi: 10.1016/j.clnu.2025.02.017. Epub 2025 Feb 18.
PMID: 40020647DERIVEDRoos PR, van den Burg EL, Schoonakker MP, van Peet PG, Numans ME, Pijl H, Westenberg JJM, Lamb HJ. Fasting-mimicking diet in type 2 diabetes reduces myocardial triglyceride content: A 12-month randomised controlled trial. Nutr Metab Cardiovasc Dis. 2025 Jul;35(7):103860. doi: 10.1016/j.numecd.2025.103860. Epub 2025 Jan 9.
PMID: 39934050DERIVEDvan den Burg EL, Schoonakker MP, Korpershoek B, Sommeling LE, Sturm CA, Lamb HJ, Pijl H, Numans ME, Adriaanse MA, van Peet PG. Self-initiated lifestyle changes during a fasting-mimicking diet programme in patients with type 2 diabetes: a mixed-methods study. BMC Prim Care. 2024 May 2;25(1):148. doi: 10.1186/s12875-024-02405-5.
PMID: 38698355DERIVEDvan den Burg EL, Schoonakker MP, van Peet PG, van den Akker-van Marle EM, Lamb HJ, Longo VD, Numans ME, Pijl H. 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. Diabetologia. 2024 Jul;67(7):1245-1259. doi: 10.1007/s00125-024-06137-0. Epub 2024 Mar 28.
PMID: 38546821DERIVEDvan den Burg EL, Schoonakker MP, van Peet PG, van den Akker-van Marle ME, Willems van Dijk K, Longo VD, Lamb HJ, Numans ME, Pijl H. 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. BMC Endocr Disord. 2020 Jun 24;20(1):94. doi: 10.1186/s12902-020-00576-7.
PMID: 32580710DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanno Pijl, MD, PhD
Leiden Univerity Medical Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Only measurements by assessors will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
January 13, 2019
First Posted
January 22, 2019
Study Start
November 5, 2018
Primary Completion
August 6, 2021
Study Completion
August 6, 2021
Last Updated
April 7, 2022
Record last verified: 2022-04