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.

Dietary lipids with potential to affect satiety: Mechanisms and evidence

“…(2012) discussed that the 1.2 kg difference in body mass between groups may not be clinically significant or even attributed to the emulsion, as this can be achieved with a negative energy balance of 100 kcal•day over the 18 week period. A more recent study investigated the concurrent application of a low-calorie diet (1500 kcal•day), an exercise program, and supplementation of 4.2 g of Olibra or 3.9 g milk fat for a 12 week period (Rebello et al 2012). They concluded no significant effect of supplementation with the emulsion on energy intake, subjective feelings of fullness or body weight/composition.…”

Systematic review of the evidence for sustained efficacy of dietary interventions for reducing appetite or energy intake

“…For EI, acute results agreed with sustained results in 12 of 14 trials (86%). In all seven studies reporting no significant acute effects, there was also no significant effect after repeated exposure (29)(30)(31)(32)(33). Of the seven studies which demonstrated significant acute effects of manipulation on EI, five (71%) reported sustained effects (16,19,(24)(25)(26).…”

Study of a delayed-release system for hard and soft capsules coated with eudragit® s100 acrylic polymers

“…According to several studies on the mechanism of satiety (Diepvens et al, 2007;Heer, 2012;Lieverse et al, 1994;Olsson et al, 2011;Rebello et al, 2012;Van Citters & Lin, 1999), gastrointestinal hormones are released depending on the intestinal food content and nutritional status of the individual and may contribute to obesity and type 2 diabetes control.…”

“…The increase in the obese population has been associated with increased incidence of diseases such as type 2 diabetes (Pontes, Sousa, & Navarro, 2009). Intervention strategies using intestinal peptide stimulation may hold promise for the control of type 2 diabetes and obesity (Rebello, Martin, Johnson, O'Neil, & Greenway, 2012). Several intestinal peptides have been implicated in gastrointestinal signalling, and the most prominent among these peptides are glucagon-like peptide (GLP-1) and YY peptide (PYY), which are associated with satiety (Soares et al, 2018), prolongation of gastric emptying, and increased insulin secretion and sensitivity (Samocha-Bonet et al, 2011;Chang et al, 2013;Meek et al, 2016).…”