Efficacy of Olibra: A 12 Week Controlled Trial

Pennington Biomedical Research Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Overweight

Obesity

Treatments

Other: Placebo

Dietary Supplement: Olibra

Study type

Interventional

Funder types

Other

Identifiers

NCT01416051

PBRC 25001

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.