The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes

N Wright, L Wilson, M Smith, B Duncan, P McHugh, N Wright, L Wilson, M Smith, B Duncan, P McHugh

Abstract

Background/objective: There is little randomised evidence using a whole food plant-based (WFPB) diet as intervention for elevated body mass index (BMI) or dyslipidaemia. We investigated the effectiveness of a community-based dietary programme. Primary end points: BMI and cholesterol at 6 months (subsequently extended).

Subjects: Ages 35-70, from one general practice in Gisborne, New Zealand. Diagnosed with obesity or overweight and at least one of type 2 diabetes, ischaemic heart disease, hypertension or hypercholesterolaemia. Of 65 subjects randomised (control n=32, intervention n=33), 49 (75.4%) completed the study to 6 months. Twenty-three (70%) intervention participants were followed up at 12 months.

Methods: All participants received normal care. Intervention participants attended facilitated meetings twice-weekly for 12 weeks, and followed a non-energy-restricted WFPB diet with vitamin B12 supplementation.

Results: At 6 months, mean BMI reduction was greater with the WFPB diet compared with normal care (4.4 vs 0.4, difference: 3.9 kg m-2 (95% confidence interval (CI)±1), P<0.0001). Mean cholesterol reduction was greater with the WFPB diet, but the difference was not significant compared with normal care (0.71 vs 0.26, difference: 0.45 mmol l-1 (95% CI±0.54), P=0.1), unless dropouts were excluded (difference: 0.56 mmol l-1 (95% CI±0.54), P=0.05). Twelve-month mean reductions for the WFPB diet group were 4.2 (±0.8) kg m-2 BMI points and 0.55 (±0.54, P=0.05) mmol l-1 total cholesterol. No serious harms were reported.

Conclusions: This programme led to significant improvements in BMI, cholesterol and other risk factors. To the best of our knowledge, this research has achieved greater weight loss at 6 and 12 months than any other trial that does not limit energy intake or mandate regular exercise.

Conflict of interest statement

NW is employed by the Royal NZ college of GPs, which is a position funded by Health Workforce New Zealand. MS and NW report being directors/shareholders in Plant Based Lifestyles Ltd, which was initiated after the completion of the BROAD study. BD, NW, MS and PMH report being trustees of the Plant Based New Zealand Health Charitable Trust. PMH reports he is a trustee on the Tairāwhiti Traditional and Complementary Therapies Research Charitable Trust (TTCTRT). LW reports being director/shareholder in Two Zesty Bananas Ltd, which was initiated after the intervention.

Figures

Figure 1
Figure 1
Patient flow.

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