The Effect of an Online Plant-Based Dietary Program on Cardiovascular Risk Factors in Persons With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Cardiometabolic Risk Factors; Glycemic Control; Diet Therapy; Cholesterol, LDL; Diet, Vegetarian; Diet, Vegan; Blood Pressure
• Interventions: Behavioral: Usual Diet; Behavioral: 12-week plant-based dietary program

• Registration Number: NCT05777746
• Lead Sponsor: UMC Utrecht

Brief 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). 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Study First Submitted: 2022-12-27
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Diet	Usual Diet	-
An online 12 week plant-based dietary program	12-week plant-based dietary program	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (mmol/mol)	Week 12
Composite of Estimated relative CVD risk (based on change in LDL-c , SBP and HbA1c)	Week 12

Secondary Outcome Measures

Name	Time	Method
Adherence (dietary index)	Week 12, 24 and 36
Blood pressure (systolic and diastolic)	Week 12 and 24
Calculated absolute CVD risk reduction (%)	Week 12, 24 and 36	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
Glycemic control (HOMA2-IR, HOMA2-B%, TyG-index, NAFLD Score)	Week 12 and 24
Lipids and lipoprotein profile	Week 12 and 24	Composition and concentration of lipoproteins and lipids, including total cholesterol, HDL-cholesterol, apolipoprotein-B, LDL-C and triglycerides
HbA1c and estimated change in absolute and relative CVD risk (based on change in LDL-c, SBP and HbA1c)	Week 12, 24 and 36	Per-protocol analysis
Inflammatory profile (CRP, neutrophil and lymphocyte count)	Week 12 and 24
Anthropometric measurements (BMI, hip/waist ratio)	Week 12, 24 and 36
Rate of Vitamin B12 and ferritin deficiency	Week 12 and 24
Quality of life(EQ-5D, self-perceived stress,and DDRQOL-R(-9), medication use)	Week 12 and 24

Trial Locations

Locations (1)

Department of Vascular Medicine UMC Utrecht; 🇳🇱 Utrecht, Netherlands