Status:
COMPLETED
Efficacy of Olibra: A 12 Week Controlled Trial
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
GNC
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 ap...
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, ...
Eligibility Criteria
Inclusion
- Healthy subjects of both sexes 18 - 60 years of age
- body mass index (BMI) between 25 and 40 kg/m2, inclusive
Exclusion
- (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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01416051
Start Date
January 1 2005
End Date
November 1 2006
Last Update
December 18 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808