Efficacy of Olibra: A 12 Week Controlled Trial - Tabular View

Tracking Information
First Received Date ^ICMJE	August 11, 2011
Last Updated Date	August 11, 2011
Start Date ^ICMJE	January 2005
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 11, 2011)	Body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] Treatment to determine if test product causes weight loss
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: August 11, 2011)	Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] To determine if treatment causes a reduction in body fat mass Food intake [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ] To determine if treatment results in a reduction in food intake
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Efficacy of Olibra: A 12 Week Controlled Trial
Official Title ^ICMJE	Efficacy of Olibra: A 12 Week Randomized Controlled Trial, and Review of Prior Studies
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 Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Overweight Obesity
Intervention ^ICMJE	Dietary Supplement: Olibra Fractionated palm oil and fractionated oat oil in the proportion of 95:5 Other Name: Fabuless Other: Placebo 100% milk fat
Study Arms	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. Intervention: Dietary Supplement: Olibra 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. Intervention: Other: Placebo
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	82
Completion Date	November 2006
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01416051
Other Study ID Numbers ^ICMJE	PBRC25001
Has Data Monitoring Committee	No
Responsible Party	Frank L. Greenway, MD, Pennington Biomedical Research Center
Study Sponsor ^ICMJE	Pennington Biomedical Research Center
Collaborators ^ICMJE	GNC
Investigators ^ICMJE
Information Provided By	Pennington Biomedical Research Center
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP