Back to resultsEfficacy of Olibra: A 12 Week Controlled Trial
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Olibra
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Overweight
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.
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Test
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Body weight
Treatment to determine if test product causes weight loss
Secondary Outcome Measures
Body composition
To determine if treatment causes a reduction in body fat mass
Food intake
To determine if treatment results in a reduction in food intake
Full Information
NCT ID
NCT01416051
First Posted
August 11, 2011
Last Updated
December 17, 2015
Sponsor
Pennington Biomedical Research Center
Collaborators
GNC
1. Study Identification
Unique Protocol Identification Number
NCT01416051
Brief Title
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
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
GNC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Olibra
Other Intervention Name(s)
Fabuless
Intervention Description
Fractionated palm oil and fractionated oat oil in the proportion of 95:5
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
100% milk fat
Primary Outcome Measure Information:
Title
Body weight
Description
Treatment to determine if test product causes weight loss
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
To determine if treatment causes a reduction in body fat mass
Time Frame
12 weeks
Title
Food intake
Description
To determine if treatment results in a reduction in food intake
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22768902
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.
Results Reference
derived
Learn more about this trial
Efficacy of Olibra: A 12 Week Controlled Trial
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