Diabetes Mellitus, Type 2Plate-DMNCT05777746
The Effect of an Online Plant-Based Dietary Program on Cardiovascular Risk Factors in Persons With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
A study testing 12-week plant-based dietary program and Usual Diet in people with Diabetes Mellitus, Type 2 and Diet, Vegetarian, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Persons with Type 2 Diabetes (T2D) are at an increased risk of cardiovascular disease (CVD) and mortality. Dietary changes are recommended by guidelines to treat T2D and reduce risk of CVD. Plant-based diets eliminate certain (i.e. vegetarian diet) or eliminate all animal based products (i.e. vegan diet). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Vegan
- What is being tested?
- 12-week plant-based dietary program and Usual Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Nov 2022to Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 Diabetes made by a physician
- Using oral glucose-lowering medication and/or an insulin regime with a stable dose during at least the last two months before the screening visit;
- Diagnosis of type 2 diabetes was made more than one year ago
- Age of 18 years or older on the day of signing the informed consent form.
- When the patients is also using lipid-lowering and/or blood pressure-lowering medication, than the dose should be stable for at least two months before the screening.
Who cannot join
- Insulin-dependent type 2 diabetes in combination with hypoglycemia unawareness. Hypoglycemia unawareness is defined as the onset of hypoglycemia before the appearance of autonomic symptoms or failure to recognize hypoglycemia.
- Two or more episodes of severe hypoglycemia (glucose < 3 mmol/L) during the last 3 months;
- Uncontrolled T2D, defined as a HbA1c >86 mmol/mol (>10%);
- Uncontrolled hypertension, defined as an office systolic blood pressure ≥ 180mmHg;
- Inability to attend at least 60% of the scheduled meetings;
- Pregnancy or a wish to get pregnant during the study period;
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- Diagnosis of familial hypercholesterolemia;
- Being diagnosed with osteoporosis.
- Known vitamin B12 deficiency, defined as serum vitamin B12 <130 pmol/L or using vitamin B12 supplements prescribed by a physician;
- Known iron deficiency defined as a serum ferritin < 25µg/L for males or < 20µg/L for females or using iron supplements prescribed by a physician;;
- The presence of any disease for which the patients uses a specific diet and where transitioning to a plant-based diet might lead to unfavorable effects on this disease as judged by the research team and/or the treating physician. An exception is a salt-restricted diet for hypertension;
- Current or planned participation in any other interventional study within 30 days of signing the informed consent form;
- Any medical, social or physiological circumstance which might interfere with the study, based on judgement by the principal investigator.
Trial locations and contacts
1 site in 1 country.
Lukas Hoes, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Department of Vascular Medicine UMC Utrecht
Utrecht, 3584 CX
Frank LJ Visseren, MD PhD, +31 88 7555555, F.L.J.Visseren@umcutrecht.nl
Frank LJ Visseren, MD PhD
About this study
Persons with Type 2 Diabetes (T2D) are at an increased risk of cardiovascular disease (CVD) and mortality. Dietary changes are recommended by guidelines to treat T2D and reduce risk of CVD. Plant-based diets eliminate certain (i.e. vegetarian diet) or eliminate all animal based products (i.e. vegan diet). Clinical trials with plant-based diets have not looked at incidence of CVD as a (primary) outcome, but at intermediate outcomes of cardiovascular risk. A meta-analysis of 8 trials including 369 persons with T2D found an effect of a plant-based diet on glycated hemoglobin (HbA1c) of -0.29% [95% CI: -0.45, -0.12%] relative to mostly (omnivorous) low-fat diets or usual diet. The 95%CI ranged from what the authors had defined as clinically trivial to clinically relevant. For lipids, a network meta-analysis in persons with T2D compared the effect of a plant-based diet to a (omnivorous) low fat diet (274 patients allocated to a plant-based diet vs 2047 patients allocated to low fat diets). Compared to omnivorous low fat diets, the mean effect of plant-based diets on LDL-Cholesterol was -0.33 mmol/L [95%CI:- 0.55, - 0.12]. However, the quality of the evidence for this estimate was graded as low, mainly due to imprecision and within-study-bias. Furthermore, plant-based diets might reduce blood pressure (BP). However, while vegetarian diets reduce BP in patients with and without hypertension, for vegan diets the effect was only significant in patients with a systolic BP>130mmHgz (see section 1.4.3). Additionally, the effect of plant-based diets on inflammation, which might also be causally related to CVD risk in persons with T2D, has not been reported in trials with persons with T2D. Furthermore, most clinical trials of plant-based diets in persons with T2D have used resource intensive interventions, like weekly group meetings and cooking sessions. The effect of an online plant-based dietary intervention, which is more scalable, has not been reported in clinical trials. Lastly, factors influencing adherence in these trials have not been reported.
In summary, plant-based diets likely lower CVD risk by lowering HbA1c, LDL cholesterol and potentially blood pressure in persons with T2D. However, estimated effect sizes are imprecise and the effect on inflammation is still unknown. Furthermore, trials to date have used resource intensive interventions. Thus, the present trial aims to study the effect of a primarily online plant-based dietary program on (cardio)vascular risk factors in persons with T2D. Additionally, adherence and factors influencing adherence will be investigated. Participants will be randomized to the intervention or control group. The intervention group will be guided to transition to a plant-based dietary pattern using an online platform and online sessions. Researchers will compare the intervention group to the control group, that continues with usual diet, to see if the cardiovascular risk profile of the intervention group improves.
- Conditions
- Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Vegan, Cardiometabolic Risk Factors, Cholesterol, LDL, Blood Pressure
- Being tested
- 12-week plant-based dietary program, Usual Diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week plant-based dietary programBehavioural
a 12-week plant-based dietary program consisting of information via an online platform, online guidance by dieticians and in online peer support groups. Patients will aim to maximize their intake of plant-based products while reducing their of animal products as much as possible.
Usual DietBehavioural
Patients in the control group continue with their usual diet and/or usual dietary care. Patients in the control group will be offered access to the online platform at 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| An online 12 week plant-based dietary program | Experimental | Not described Receives: Behavioral: 12-week plant-based dietary program |
| Usual Diet | Other | Not described Receives: Behavioral: Usual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (mmol/mol)
Measured: Week 12
Composite of Estimated relative CVD risk (based on change in LDL-c , SBP and HbA1c)
Measured: Week 12
Secondary outcomes (10)
Calculated absolute CVD risk reduction (%)
Using baseline parameters (e.g. baseline LDL-C, BP, HbA1c, manifest CVD, duration of diabetes) and the risk prediction model DIAL2/SCORE-2(OP), the absolute CVD risk at baseline is calculated. The expected absolute risk reduction is calculated using changes in CVD risk profile after 12 and 24 weeks
Measured: Week 12, 24 and 36
HbA1c and estimated change in absolute and relative CVD risk (based on change in LDL-c, SBP and HbA1c)
Per-protocol analysis
Measured: Week 12, 24 and 36
Glycemic control (HOMA2-IR, HOMA2-B%, TyG-index, NAFLD Score)
Measured: Week 12 and 24
Lipids and lipoprotein profile
Composition and concentration of lipoproteins and lipids, including total cholesterol, HDL-cholesterol, apolipoprotein-B, LDL-C and triglycerides
Measured: Week 12 and 24
Blood pressure (systolic and diastolic)
Measured: Week 12 and 24
Inflammatory profile (CRP, neutrophil and lymphocyte count)
Measured: Week 12 and 24
Quality of life(EQ-5D, self-perceived stress,and DDRQOL-R(-9), medication use)
Measured: Week 12 and 24
Anthropometric measurements (BMI, hip/waist ratio)
Measured: Week 12, 24 and 36
Adherence (dietary index)
Measured: Week 12, 24 and 36
Rate of Vitamin B12 and ferritin deficiency
Measured: Week 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start29 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 UMC UtrechtThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr.Frank L.J. Visseren, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777746
- Sponsor's protocol ID
- NL80378.041.22
- Acronym
- Plate-DM
- Status last verified
- Mar 2023
- First submitted
- 27 Dec 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Request for IPD should be directed to the PI. The PI will judge whether request are appropriate and can be granted within the existing rules and regulations.
Publications
Hoes LLF, Geleijnse JM, Bemelmans RHH, Muller AF, de Ranitz-Greven WL, van Sloten T, Visseren FLJ, Koopal C. An online, predominantly plant-based, dietary intervention for improving cardiovascular risk: A randomized controlled trial in people with type 2 diabetes. Am Heart J. 2026 Aug;298:107436. doi: 10.1016/j.ahj.2026.107436. Epub 2026 Apr 2.
PubMed 41935557
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Online Plant-Based Dietary Program on Cardiovascular Risk Factors in Persons With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05777746
- Acronym / sponsor ID
- Plate-DM / NL80378.041.22
- Conditions
- Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Vegan, Cardiometabolic Risk Factors, Cholesterol, LDL, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 21 Mar 2023 (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.
Persons with Type 2 Diabetes (T2D) are at an increased risk of cardiovascular disease (CVD) and mortality. Dietary changes are recommended by guidelines to treat T2D and reduce risk of CVD. Plant-based diets eliminate certain (i.e. vegetarian diet) or eliminate all animal based products (i.e. vegan diet). Clinical trials with plant-based diets have not looked at incidence of CVD as a (primary) outcome, but at intermediate outcomes of cardiovascular risk. A meta-analysis of 8 trials including 369 persons with T2D found an effect of a plant-based diet on glycated hemoglobin (HbA1c) of -0.29% [95% CI: -0.45, -0.12%] relative to mostly (omnivorous) low-fat diets or usual diet. The 95%CI ranged from what the authors had defined as clinically trivial to clinically relevant. For lipids, a network meta-analysis in persons with T2D compared the effect of a plant-based diet to a (omnivorous) low fat diet (274 patients allocated to a plant-based diet vs 2047 patients allocated to low fat diets). Compared to omnivorous low fat diets, the mean effect of plant-based diets on LDL-Cholesterol was -0.33 mmol/L [95%CI:- 0.55, - 0.12]. However, the quality of the evidence for this estimate was graded as low, mainly due to imprecision and within-study-bias. Furthermore, plant-based diets might reduce blood pressure (BP). However, while vegetarian diets reduce BP in patients with and without hypertension, for vegan diets the effect was only significant in patients with a systolic BP>130mmHgz (see section 1.4.3). Additionally, the effect of plant-based diets on inflammation, which might also be causally related to CVD risk in persons with T2D, has not been reported in trials with persons with T2D. Furthermore, most clinical trials of plant-based diets in persons with T2D have used resource intensive interventions, like weekly group meetings and cooking sessions. The effect of an online plant-based dietary intervention, which is more scalable, has not been reported in clinical trials. Lastly, factors influencing adherence in these trials have not been reported.
In summary, plant-based diets likely lower CVD risk by lowering HbA1c, LDL cholesterol and potentially blood pressure in persons with T2D. However, estimated effect sizes are imprecise and the effect on inflammation is still unknown. Furthermore, trials to date have used resource intensive interventions. Thus, the present trial aims to study the effect of a primarily online plant-based dietary program on (cardio)vascular risk factors in persons with T2D. Additionally, adherence and factors influencing adherence will be investigated. Participants will be randomized to the intervention or control group. The intervention group will be guided to transition to a plant-based dietary pattern using an online platform and online sessions. Researchers will compare the intervention group to the control group, that continues with usual diet, to see if the cardiovascular risk profile of the intervention group improves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| An online 12 week plant-based dietary program | Experimental | Behavioral: 12-week plant-based dietary program |
| Usual Diet | Other | Behavioral: Usual Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Type 2 Diabetes made by a physician
- Using oral glucose-lowering medication and/or an insulin regime with a stable dose during at least the last two months before the screening visit;
- Diagnosis of type 2 diabetes was made more than one year ago
- Age of 18 years or older on the day of signing the informed consent form.
- When the patients is also using lipid-lowering and/or blood pressure-lowering medication, than the dose should be stable for at least two months before the screening.
Key exclusion criteria (13 listed)
- Insulin-dependent type 2 diabetes in combination with hypoglycemia unawareness. Hypoglycemia unawareness is defined as the onset of hypoglycemia before the appearance of autonomic symptoms or failure to recognize hypoglycemia.
- Two or more episodes of severe hypoglycemia (glucose < 3 mmol/L) during the last 3 months;
- Uncontrolled T2D, defined as a HbA1c >86 mmol/mol (>10%);
- Uncontrolled hypertension, defined as an office systolic blood pressure ≥ 180mmHg;
- Inability to attend at least 60% of the scheduled meetings;
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 |
|---|---|---|
| 12-week plant-based dietary programa 12-week plant-based dietary program consisting of information via an online platform, online guidance by dieticians and in online peer support groups. Patients will aim to maximize their intake of plant-based products while reducing their of animal products as much as possible. | Behavioural | An online 12 week plant-based dietary program |
| Usual DietPatients in the control group continue with their usual diet and/or usual dietary care. Patients in the control group will be offered access to the online platform at 24 weeks. | Behavioural | Usual Diet |
Primary outcome
Change in HbA1c (mmol/mol)
Time frame: Week 12
Composite of Estimated relative CVD risk (based on change in LDL-c , SBP and HbA1c)
Time frame: Week 12
10 secondary outcomes
Calculated absolute CVD risk reduction (%)
Time frame: Week 12, 24 and 36
HbA1c and estimated change in absolute and relative CVD risk (based on change in LDL-c, SBP and HbA1c)
Time frame: Week 12, 24 and 36
Glycemic control (HOMA2-IR, HOMA2-B%, TyG-index, NAFLD Score)
Time frame: Week 12 and 24
Lipids and lipoprotein profile
Time frame: Week 12 and 24
Blood pressure (systolic and diastolic)
Time frame: Week 12 and 24
Inflammatory profile (CRP, neutrophil and lymphocyte count)
Time frame: Week 12 and 24
Quality of life(EQ-5D, self-perceived stress,and DDRQOL-R(-9), medication use)
Time frame: Week 12 and 24
Anthropometric measurements (BMI, hip/waist ratio)
Time frame: Week 12, 24 and 36
Adherence (dietary index)
Time frame: Week 12, 24 and 36
Rate of Vitamin B12 and ferritin deficiency
Time frame: Week 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: PubMed 41935557Hoes LLF, Geleijnse JM, Bemelmans RHH, Muller AF, de Ranitz-Greven WL, van Sloten T, Visseren FLJ, Koopal C. An online, predominantly plant-based, dietary intervention for improving cardiovascular risk: A randomized controlled trial in people with type 2 diabetes. Am Heart J. 2026 Aug;298:107436. doi: 10.1016/j.ahj.2026.107436. Epub 2026 Apr 2.
- Plate-DM UMC UtrechtLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Request for IPD should be directed to the PI. The PI will judge whether request are appropriate and can be granted within the existing rules and regulations.
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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.
Lukas Hoes, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week plant-based dietary program and Usual Diet in people with Diabetes Mellitus, Type 2 and Diet, Vegetarian, run by UMC Utrecht 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 21 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact F.L.J. Visseren, MD PhD (+31 88 7555555, f.l.j.visseren@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (mmol/mol) (time frame: Week 12). 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 NCT05777746, which also lists 1 linked publication.
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 21 Mar 2023.