(P25-036-20) A Nutrient-Dense Supplement Shake Improves Weight Loss and Metabolic Markers in Overweight Individuals: A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial

Objectives: To determine if greater weight loss and improvement in metabolic outcomes could be achieved with twice daily consumption of a proprietary supplement shake containing high protein and fiber (HPF) as compared to an isocaloric low protein, lower fiber placebo (P).

Methods: In an independently conducted randomized, double-blind, placebo-controlled, multi-center clinical trial, healthy overweight and obese adults (n = 206, BMI 27-35 kg/m², 70% Female) were equally assigned to HPF or P. All participants were instructed to follow a 500-calorie deficit diet from estimated daily energy requirements using a dietary exchange program and were asked to consume HPF or P 30 min before breakfast and lunch for 12 weeks. The supplement was a commercially available product composed of protein, fruit, vegetable, and plant powders, as well as vitamins, minerals, pre-, and probiotics. Body weight, body composition, and blood samples were collected at days (D) 0 and 84. Statistics were conducted by ANCOVA or repeated measure ANCOVA modeling using sex and baseline values as covariates, with time and treatment as within- and between-subject variables, respectively. Per protocol analyses were included for the 133 adults who completed the study.

Results: Weight loss occurred throughout the study in both groups. HPF had greater weight loss at D 84 vs P (-4.0% vs -2.2% body weight, respectively; p < 0.05). Total cholesterol, LDL, and oxidized LDL decreased to a greater extent following HPF at D 84 (p < 0.05 vs D 0 and vs P), with no change in HDL cholesterol. The increase in serum adiponectin from D 0 to D 84 was greater in HPF vs P (p < 0.05) with no change in leptin. Percent body fat tended to decrease throughout the study in both groups (HPF: -1.44%, P: -1.27%; p = 0.056) with no differences between groups. There were no clinically relevant changes in assessed safety outcomes in either group.

Conclusions: A HPF supplement taken as a preload before breakfast and lunch improved weight loss and metabolic outcomes such as total, LDL and oxidized LDL cholesterol compared to a calorie-matched placebo. This study suggests nutrient factors other than calorie reduction alone influence the success of a weight loss regimen, potentially including nutrient density, protein and fiber content.

This trial was registered at clinicaltrials.gov as NCT03057873.

Funding Sources: This study was funded by Beachbody, LLC.