Efficacy of Olibra: A 12 Week Controlled Trial
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | January 2005 |
| End Date: | November 2006 |
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.
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.
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.
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.
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.
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