Supplementary file 1_Plant-based caloric restriction diets versus conventional calorie-restricted diets for weight loss and metabolic health in obese adults: a 12-week randomized, open-label, non-inferiority trial.docx

BackgroundPlant-based caloric restriction diet (PB-CRD), combining plant-based nutrition with intermittent caloric restriction, represent a structured dietary strategy to obesity management. This study compared the effects of PB-CRD and calorie-restricted diet (CRD) on weight loss, and metabolic health, hypothesizing that PB-CRD is non-inferior to CRD for weight loss.
MethodsIn this 12-week, open-label, non-inferiority trial, 80 participants with obesity (body mass index [BMI]: 28–40 kg/m2, age: 18–45 years) were randomized in a 1:1 ratio to either a PB-CRD (‘5 + 2’ pattern: 5 days/week of provided standardized plant-based meals and 2 days/week of self-selected meals within prescribed caloric targets) or a CRD (7 days/week of self-selected meals within prescribed caloric targets). Both groups adhered to the same daily energy intake targets of 1,600 kcal/day (men) and 1,300 kcal/day (women). The primary outcome was weight loss, while secondary outcomes included body composition, glucose and lipid metabolism, liver and kidney function, oxidative stress, and inflammation markers.
ResultsOf the 80 participants (mean BMI: 32.03 ± 3.46 kg/m2; mean age: 34.78 ± 7.12 years; 31 males), 52 (65%) completed the 12-week trial (n = 28 in PB-CRD and n = 24 in CRD group). Both groups achieved significant within-group weight loss from baseline (p < 0.05): 5.11 kg in the CRD and 6.56 kg in the PB-CRD group. The between-group difference was −1.44 kg (95% confidence interval [CI]: −3.27 to 0.39), which remained within the pre-specified non-inferiority margin of 0.5 kg. Compared to the CRD, the PB-CRD group demonstrated significantly greater between-group reductions in total body fat percentage (2.96 [95% CI: 1.67–4.25], p = 0.028), uric acid, and superoxide dismutase levels, as well as increased blood urea nitrogen (p < 0.05). Additionally, the PB-CRD group exhibited significant within-group improvements in visceral fat mass, HOMA-IR, total cholesterol, liver function markers, and inflammatory markers (p < 0.05), with no substantial differences between groups.
ConclusionBoth PB-CRD and CRD were effective for weight loss, with PB-CRD demonstrating non-inferiority. Furthermore, PB-CRD offered superior benefits in reducing total body fat and improving uric acid metabolism, while improving insulin sensitivity and liver function in adults with obesity.
Clinical trial registrationIdentifier ChiCTR1800015156.