Efficacy of Olibra: A 12 Week Controlled Trial

Phase 1

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: Olibra; Other: Placebo

• Registration Number: NCT01416051
• Lead Sponsor: Pennington Biomedical Research Center

Brief 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.

Detailed 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 Timeline

• Study Start: 2005-01
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Healthy subjects of both sexes 18 - 60 years of age
• body mass index (BMI) between 25 and 40 kg/m2, inclusive

Exclusion Criteria

• (1) participation in another clinical trial or receipt of an investigational product 30 days prior to enrollment
• (2) a dietary restraint score of > 13
• (3) weight loss of 4.5 kg or more in the preceding three months
• (4) use of tobacco products, nicotine gum or nicotine patch
• (5) a medical condition or taking regular medication except oral contraceptives and hormone replacement therapy
• (6) use of a nutritional product or dietary supplement or program which might interfere with the conduct of the study or place the subject at risk
• (7) history of alcohol or other drug abuse in the preceding one year
• (8) pregnancy, lactation, post-partum less than six months, planning a pregnancy during the study or not using an acceptable method of contraception
• (9) fasting blood sugar ≥ 126 mg/dl
• (10) known allergy or sensitivity to any ingredient in the supplement
• (11) clinically significant deviations in normal laboratory values
• (12) irregular meal-times, and
• (13) unwilling to eat yogurt at test meals.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Olibra	Subjects consumed a vegetable oil emulsion in yogurt at a food intake test and were asked to consume the product twice daily for 12 weeks.
Control Group	Placebo	Subjects were given a placebo of milk fat in yogurt at food intake tests and asked to consume the placebo twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Body weight	12 weeks	Treatment to determine if test product causes weight loss

Secondary Outcome Measures

Name	Time	Method
Body composition	12 weeks	To determine if treatment causes a reduction in body fat mass
Food intake	4 weeks	To determine if treatment results in a reduction in food intake

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States