Efficacy of Olibra: A 12 Week Controlled Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: Olibra; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test; 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.	Dietary supplement: Olibra; Fractionated palm oil and fractionated oat oil in the proportion of 95:5; Other Names: Fabuless
Placebo Comparator: Control Group; 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.	Other: Placebo; 100% milk fat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Treatment to determine if test product causes weight loss	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	To determine if treatment causes a reduction in body fat mass	12 weeks
Food intake	To determine if treatment results in a reduction in food intake	4 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: GNC

Publications and helpful links

General Publications

• Rebello CJ, Martin CK, Johnson WD, O'Neil CE, Greenway FL. 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (Estimate): August 12, 2011

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: PBRC 25001