Meal Replacement Provides Additional Benefits for Weight and Visceral Fat Reduction in Prediabetic Individuals: A Randomized Clinical Trial.

BACKGROUND: Meal replacements (MRs) have been shown to improve cardiometabolic risk factors; however, their effects on visceral fat and metabolic characteristics in individuals with prediabetes remain insufficiently investigated. This study was aimed to demonstrate the effectiveness of MR combined with lifestyle intervention in improving weight, visceral fat area (VFA), blood pressure, and biochemical indicators in participants with prediabetes comorbid with overweight/obesity. MATERIALS AND METHODS: According to the inclusion and exclusion criteria, 100 prediabetic participants (25 kg/m2 ≤ body mass index [BMI] ≤ 35 kg/m2) were recruited and randomly divided into the lifestyle intervention group (LSI group; received guidance on lifestyle interventions) and the lifestyle intervention combined with MR group (LSI + MR group; received a nutrient-rich and low-carbohydrate MR to replace the staple food of two meals or replace one regular meal while receiving lifestyle interventions). Forty-two participants in the LSI group and 45 in the LSI + MR group completed the trial. Anthropometric indexes were collected and biochemical indexes were tested at baseline and 12 weeks post-intervention. RESULTS: Compared with the LSI group, the LSI + MR group showed greater percentage reductions in weight (-5.3% ± 5.5% vs. -8.3% ± 4.5%; p < 0.01) and VFA (-11.9% ± 21.0% vs. -22.7% ± 23.8%; p < 0.05). And there were significant time × group interaction effects for weight (F = 5.296, p = 0.023), BMI (F = 5.124, p = 0.025), and VFA (F = 9.177, p = 0.003). For blood pressure, postprandial glucose, insulin resistance, liver enzymes, and lipids, there were only time effects (p < 0.05) but no time × group interaction effects (p > 0.05). Subgroup analyses suggested that MR-related benefits varied by baseline VFA, with greater improvement in 2-h postprandial plasma glucose among participants with VFA < 100 cm2 and greater reductions in weight, triglyceride, and total cholesterol among those with VFA ≥ 100 cm2. CONCLUSION: Lifestyle intervention combined with MR resulted in greater reductions in body weight and VFA than lifestyle intervention alone in individuals with prediabetes and overweight/obesity. The additional metabolic benefits of MR appeared to vary according to baseline visceral adiposity. Trial Registration: ClinicalTrials.gov identifier: NCT05273840.