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

J Diabetes Sci Technol. 2012 May 1;6(3):695-708. doi: 10.1177/193229681200600326.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Review

MeSH terms

  • Adult
  • Analysis of Variance
  • Anti-Obesity Agents / adverse effects
  • Anti-Obesity Agents / therapeutic use*
  • Appetite Regulation / drug effects
  • Body Composition / drug effects
  • Chi-Square Distribution
  • Dietary Fats / adverse effects
  • Dietary Fats / therapeutic use*
  • Double-Blind Method
  • Eating / drug effects
  • Emulsions / adverse effects
  • Emulsions / therapeutic use*
  • Humans
  • Louisiana
  • Middle Aged
  • Obesity / diagnosis
  • Obesity / drug therapy*
  • Obesity / physiopathology
  • Obesity / psychology
  • Satiety Response / drug effects
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Waist Circumference
  • Waist-Hip Ratio
  • Weight Loss / drug effects

Substances

  • Anti-Obesity Agents
  • Dietary Fats
  • Emulsions

Associated data

  • ClinicalTrials.gov/NCT01416051