Randomised Controlled Trial, Double-blind, to Measure Efficiency and Tolerance of a New Food Supplement OMNIA on Body Fat Mass Reduction in Overweight Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Vivatech
- 入组人数
- 86
- 主要终点
- Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and efficacy of a food supplement OMNIA compared to a placebo in reducing the body fat mass in 70 overweight subjects during 12 weeks treatment.
详细描述
Overweight and obesity represent a serious public health issue. These conditions are characterized by an abnormal or excessive accumulation of body fat mass and they are related to an increase risk of developing chronic diseases such as cardiovascular, diabetes, arthrosis and certain kind of cancer (breast; colon). It's thus necessary to find new products able to counteract both overweight and obesity.
Omnia is a food supplement based on a Phaseolus vulgaris extract. It has pancreatic amylase inhibition properties.
In the following clinical trial, OMNIA will be administrated to a group of overweight subjects in order to evaluate its efficacy on reducing the body fat mass. Its action will be compared to a placebo administered to a second group of overweight volunteers with the same modalities as OMNIA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25≤ BMI<30 kg/m2
- •excess of fat mass
- •food habits : 3 meals a day and a glucides intake equivalent to at least 40% of daily energy (i.e.: glucides intake at each meal)
- •Able to give a written or verbal informed consent
- •Affiliated or beneficiary of social security
排除标准
- •Weight loss/gain > 2kg within the preselection period (2 weeks)
- •Abnormal blood results at V0
- •Physical activity (sport; lifestyle) modification planned or ongoing during the trial
- •Severe pathologies/disorders (bulimia; anorexia; diabetes; cancer...) emerging
- •Pregnancy during the study
- •Consent withdrawal
- •Allergy to Omnia
- •observance <60%
- •Investigator or promotor decision
研究组 & 干预措施
Omnia group
After 2 weeks of run-in period, subjects take 2 Omnia pills per meal (3 meals a day) for 12 weeks.
干预措施: Omnia (Dietary Supplement)
Placebo group
After 2 weeks of run-in period, subjects take 2 Placebo pills per meal (3 meals a day) for 12 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
时间窗: 12 weeks
次要结局
- change from baseline in Body Mass Index (BMI)(6, 12 weeks)
- change from baseline on weight(6, 12 weeks)
- change from baseline on the ratio fat/lean body mass measured by DEXA(12 weeks)