An online, Predominantly Plant-based, Dietary Intervention for Improving Cardiovascular Risk: a Randomized Controlled Trial in People with Type 2 Diabetes

Abstract

Aim Proof-of-concept study evaluating the effect of a 12-week, predominantly plant-based online dietary intervention compared to usual diet on change in glycated hemoglobin (HbA1c) and estimated cardiovascular disease (CVD) risk in people with type 2 diabetes (T2D). Methods People with T2D on stable medication were randomized to usual diet or a 12-week, predominantly plant-based online dietary intervention. Coprimary outcomes were change in HbA1c and estimated relative CVD risk calculated from change in HbA1c, low-density lipoprotein cholesterol (LDL-c), and systolic blood pressure (SBP). Results In total, 49 people were randomized, with 48 completing the trial. Mean age was 64 ± 9 years, and 50% were male. There was a nonsignificant 3 (95% CI −7, 2) mmol/mol reduction in HbA1c and a 16% (95% CI −29, 1%) estimated relative CVD risk reduction in the plant-based compared to the usual diet group. Plant-based to total protein intake increased by 35% (95% CI 21, 49%), saturated fat intake decreased by 4 energy-percent (95% CI −6, −1), weight decreased by 2.0 kg (95% CI −3.6; −0.5) and LDL-c by 0.3 mmol/L (95% CI −0.6; −0.0) in the plant-based compared to the usual diet group. There was no effect on SBP (−3 mmHg) (95% CI −10, 4). Medication use remained stable. No people experienced clinically important hypoglycemia. Mild gastrointestinal complaints in the plant-based group were generally well tolerated. Conclusions An online plant-based dietary intervention did not significantly reduce HbA1c and resulted in a trend toward a 16% estimated reduction in relative CVD risk. Several secondary outcomes, including dietary components, weight, and LDL-c improved. Trial Registration This trial was registered at clinicaltrials.gov under NCT05777746.