Diabetes Mellitus, Type 2NCT03811587
Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
A study testing Fasting Mimicking diet in people with Diabetes Mellitus, Type 2, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Fasting Mimicking diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Nov 2018to 6 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Fasting Mimicking diet
- Keywords
- Diet, Fasting
- Medical subject headings
- Diabetes Mellitus, Type 2, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting Mimicking dietOther
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 group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Diabetes 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. Receives: Other: Fasting Mimicking diet |
| Control group | No intervention | Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HbA1c
Measured: 12 months
Dosage of antidiabetic medication used
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start5 Nov 2018
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to the intervention or control group.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation, Health Holland, IFOM ETS - The AIRC Institute of Molecular Oncology, L-Nutra
- Responsible party
- Principal investigator, Hanno Pijl, Leiden University Medical Center
- Investigators
- Hanno Pijl, MD, PhD, Principal investigator, Leiden Univerity Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811587
- Sponsor's protocol ID
- NL63892.058.18 - P18.049
- Status last verified
- Apr 2022
- First submitted
- 13 Jan 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen R, Westenberg JJM, van den Burg EL, Schoonakker MP, le Cessie S, van Peet PG, Pijl H, Lamb HJ. Effects of a Fasting-mimicking Diet on MRI-assessed Cardiac Structure and Function in Participants with Type 2 Diabetes. Radiol Cardiothorac Imaging. 2026 Aug;8(4):e250547. doi: 10.1148/ryct.250547.
PubMed 42530457van den Burg EL, van Peet PG, Schoonakker MP, Esmeijer AC, Lamb HJ, Numans ME, Pijl H, van den Akker-van Marle ME. 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. BMC Prim Care. 2025 Nov 10;26(1):351. doi: 10.1186/s12875-025-03027-1.
PubMed 41214519Schoonakker 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.
PubMed 40425403van 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.
PubMed 40020647Roos 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.
PubMed 39934050van 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.
PubMed 38698355van 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.
PubMed 38546821van 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.
PubMed 32580710
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03811587
- Acronym / sponsor ID
- NL63892.058.18 - P18.049
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diet, Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation, Health Holland, IFOM ETS - The AIRC Institute of Molecular Oncology, L-Nutra
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomised to the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Fasting Mimicking dietDiabetes 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 intervention | –Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting Mimicking dietThe 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. | Other | Treatment group |
Primary outcome
Concentration of HbA1c
Time frame: 12 months
Dosage of antidiabetic medication used
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 42530457Chen R, Westenberg JJM, van den Burg EL, Schoonakker MP, le Cessie S, van Peet PG, Pijl H, Lamb HJ. Effects of a Fasting-mimicking Diet on MRI-assessed Cardiac Structure and Function in Participants with Type 2 Diabetes. Radiol Cardiothorac Imaging. 2026 Aug;8(4):e250547. doi: 10.1148/ryct.250547.
- Derived from this study: PubMed 41214519van den Burg EL, van Peet PG, Schoonakker MP, Esmeijer AC, Lamb HJ, Numans ME, Pijl H, van den Akker-van Marle ME. 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. BMC Prim Care. 2025 Nov 10;26(1):351. doi: 10.1186/s12875-025-03027-1.
- Derived from this study: PubMed 40425403Schoonakker 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.
- Derived from this study: PubMed 40020647van 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.
- Derived from this study: PubMed 39934050Roos 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.
- Derived from this study: PubMed 38698355van 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.
- Derived from this study: PubMed 38546821van 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.
- Derived from this study: PubMed 32580710van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanno Pijl, MD, PhD principal investigator
Leiden Univerity Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting Mimicking diet in people with Diabetes Mellitus, Type 2, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of HbA1c (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811587, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.