Efficacy of Olibra: A 12 Week Controlled Trial

Obesity Clinical Trial

Official title: Efficacy of Olibra: A 12 Week Randomized Controlled Trial, and Review of Prior Studies

Status Completed

Clinical Trial Summary

Today's obesogenic environment, favors behavioral choices that lead to an excess of energy intake over expenditure, and consequently weight gain. Intervention strategies that harness the body's own appetite and satiety regulating signals could provide an effective means of countering excessive energy intake. The purpose of this study was to investigate whether a vegetable oil emulsion (Olibra) would result in weight loss that was associated with a reduction in food intake.

Clinical Trial Description

71 healthy subjects were enrolled (60 females, 11 males; Age: 18 - 60 years, BMI 25 - 40 kg/m2) in a two-phased, randomized, placebo-controlled, double-blind, parallel trial. During a 12-week period, Olibra was compared with a placebo (milk fat). Food intake testing was conducted on three days and anthropometric data was collected on 7 days. Key outcome measures were, body weight, body composition, energy intake, and appetite ratings. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

• NCT number: NCT01416051
• Study type: Interventional
• Source: Pennington Biomedical Research Center
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2005
• Completion date: November 2006