Efficacy of Olibra: a 12-week randomized controlled trial and a review of earlier studies

Abstract

Background: Intervention strategies that harness the body's appetite and satiety regulating signals provide a means of countering excessive energy intake.

Methods: Eighty-two subjects were enrolled (18-60 years, body mass index: 25-40 kg/m(2)) in a randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, the effects of Olibra™ fat emulsion (2.1 g twice daily) on food intake, appetite, satiety, weight, and body composition were compared with those of a twice daily administered placebo (1.95 g milk fat). On days -7, 0, and 28, Olibra or the placebo added to 200 g of yogurt was served at breakfast and lunch. Food intake, appetite, and satiety were assessed after lunch and dinner. Body weight was measured on days -7, 0, 14, 28, 56, and 84. Body fat, waist circumference, and waist-hip ratio were determined on days 0 and 84. The Eating Inventory was administered at screening and on day 28. Data relating to 71 subjects were analyzed using analysis of covariance.

Results: At 12 weeks, body weight was reduced in the test group (2.17 ± 0.46 kg standard error of the mean, p < .0001) and the control group (1.68 ± 0.42 kg, p < .0001). Waist circumference decreased by 2.93 ± 0.85 cm in the test group (p = .001) and by 1.78 ± 0.74 cm in the control group (p = .02). Differential weight and waist circumference reductions were not significant. Hunger scores (Eating Inventory) decreased more in the test group (p = .0082). Differential group effects were not significant for body fat, waist-hip ratio, food intake, appetite, and satiety.

Conclusions: At this dose, Olibra did not exert a consistent effect on food intake, appetite regulation, body weight, or body composition.

Trial registration: ClinicalTrials.gov NCT01416051.

© 2012 Diabetes Technology Society.

Figures

Figure 1

Subject recruitment, randomization, and continuance with the study

Figure 2

Hunger scores on EI collected at screening and prior to food intake test on day 28 (p = .0082). Values are mean ± SEM.