Clinical trial NCT01416051: Efficacy of Olibra: A 12 Week Controlled Trial
Official title: Efficacy of Olibra: A 12 Week Randomized Controlled Trial, and Review of Prior Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Overweight
Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: GNC
First posted: 2011-08-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 12 weeks
measure: Food intake
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: 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.