Efficacy of Olibra: A 12 Week Controlled Trial

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.

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.