Study of the Consumption of Nutriose on Satiety, Weight Loss and Fat Mass Reducing in Overweight Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." Recent work in China in overweight volunteers have shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of interest in the management of overweight or obese. Among the possible mechanisms of action, are the metabolites produced by colonic fermentation of NUTRIOSE.
The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on satiety and satiation and changes in colonic flora and its metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy people
- •aged between 20 and 50 years
- •BMI between 27 and 29 kg/m2
- •without metabolic syndrome
- •no pregnant nor nursing women
- •covered by Social Security
- •negative serology for hepatitis B/C and HIV
- •who signed the informed consent form
排除标准
- •persons abusing drugs (laxatives, anti-diarrheal, agents acting on satiety)
- •person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study
- •person intolerant to gluten and / or allergic to wheat flour
- •person in diet during the last 3 months
- •person in vegetarian or vegan diet
- •person who donated blood during the 3 months preceding the study
- •Inclusion in another clinical study
- •subjects receiving over 4,500 Euros in the last 12 months (including the present study)
- •subjects presenting risk of non-compliance in the opinion of the recruiting doctor.
结局指标
主要结局
body weight
时间窗: D-7; D28; D56; D84
次要结局
- satiety(D-7; D28; D56; D84)
- energy intake(D-7; D28; D56; D84)
- LDL cholesterol(D-7; D28; D56; D84)
- BMI(D-7; D28; D56; D84)
- HDL cholesterol(D-7; D28; D56; D84)
- body fat(D-7; D28; D56; D84)
- triglyceridemia(D-7; D28; D56; D84)
- waist size(D-7; D28; D56; D84)
- glycemia(D-7; D28; D56; D84)
- insulinemia(D-7; D28; D56; D84)
- total cholesterol(D-7; D28; D56; D84)
- HOMA(D-7; D28; D56; D84)
- microbiota(D-7; D28; D56; D84)
- blood pressure(D-7; D28; D56; D84)
- digestive tolerance(D-7; D28; D56; D84)