Efficacy of Olibra: A 12 Week Randomized Controlled Trial, and Review of Prior Studies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects of both sexes 18 - 60 years of age
- •body mass index (BMI) between 25 and 40 kg/m2, inclusive
排除标准
- •(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.
结局指标
主要结局
Body weight
时间窗: 12 weeks
Treatment to determine if test product causes weight loss
次要结局
- Body composition(12 weeks)
- Food intake(4 weeks)
研究者
Frank Greenway
Principal Investigator
Pennington Biomedical Research Center