Effects of Whey Protein Pre-meals on Post-prandial Glucose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Post-prandial glucose
研究概览
简要总结
The aim of this project was to determine if an administration of either 10 g of whey protein isolate or 10 g of whey protein microgels 30 or 10 min before a standard meal could reduce postprandial glucose response in obese subjects.
详细描述
Monocentric, controlled, randomized, open, complete cross-over study design where participants will take 2 test products or water (negative control) at 2 different time points.
The targeted population will be 16 completely healthy males and females at risk for pre-diabetes.
Primary objective: To quantify the effects of whey protein pre-meals administrated at 30 or 10 min before a meal on post-prandial glucose in the interstitial tissue, as compared to water as negative control.
Secondary objective: To compare glucose response of the different pre-meals (water, whey protein isolate, whey protein micelles).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participant
- •Age between 40 and 65 years
- •BMI higher than 27.0 kg/m2
- •Sedentarity (no more than 30 min of walk per day).
- •Able to understand and sign an informed consent form
排除标准
- •Any known metabolic disease including diabetes or chronic drug intake (aspirin, vitamin C and mineral supplements, steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics...) possibly impacting (to the opinion of the medical doctor):
- •The digestion or absorption of nutrients
- •The postprandial glucose response
- •Major medical/surgical event requiring hospitalization in the last 3 months, to the opinion of the medical doctor
- •Known allergy and intolerance to products components
- •Medically known cutaneous hypersensitivity to adhesives and plasters
- •Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
- •Volunteer who cannot be expected to comply with the protocol
- •Subject having a hierarchical link with the research team members
结局指标
主要结局
Post-prandial glucose
时间窗: Hour 0 to hour 2 after standard meal consumption
Incremental area under the curve
次要结局
- C max glucose(Hour 0 to hour 2 after standard meal consumption)
- T max glucose(Hour 0 to hour 2 after standard meal consumption)