Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
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
- Incremental Area under the Curve (iAUC) of plasma glucose
研究概览
简要总结
Sugar-sweetened beverages are the main source of added sugars in most Westernized countries, and for this reason constitute a primary target for sugar reduction by many companies, including Nestlé. Instead of using high-intensity sweeteners which are non-caloric in nature, an alternative would be to reduce sugars without altering sweetness.
In this protocol, the general goal is to investigate the relative contribution of sweet taste perception and sugar intake on post-prandial glucose response. 4 different nutritional products will be tested by 16 healthy subjects in a crossover design.
详细描述
After enrollment, participants will be asked to come to the investigational site 6 times for:
- two sensory tests dedicated to assess the sensory capacity of the participants from the same sensory test repeated twice, for better consistency.
- 4 testing visits for a 3-h blood kinetics after each product intake. These visits will be scheduled on different days separated by a washout period of at least one week. Outcomes will be glycemia and insulinemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •BMI between 18.5 and 29.9 kg/m2
- •Fasting capillary blood glucose level ≤ 7 mmol/L
- •Able to understand and sign an informed consent form
排除标准
- •Pregnancy on anamnesis
- •Lactating mothers
- •Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
- •Medically-treated diabetes mellitus or use of anti-hyperglycemic drugs or insulin
- •Family history of type 2 diabetes (parents)
- •Any other metabolic disease possibly impacting the postprandial glucose and insulin response (to the opinion of the medical doctor)
- •Known ageusia or other tasting trouble
- •Chronic intake of medications known to affect glucose tolerance to the opinion of the investigator (steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics)
- •Presence of disease or intake of drug that affects digestion and absorption of nutrients, to the opinion of the medical doctor
- •Major medical/surgical event requiring hospitalisation in the last 3 months
结局指标
主要结局
Incremental Area under the Curve (iAUC) of plasma glucose
时间窗: 0 to 3 hours post product intake
Area under the curve
次要结局
- Incremental Area under the Curve (iAUC) of plasma insulin(0 to 3 hours post product intake)
- Cmax of plasma insulin(between 0 and 3 hours post product intake)
- Cmax of plasma glucose(between 0 and 3 hours post product intake)
- Tmax of plasma insulin(between 0 and 3 hours post product intake)
- Sensory tasting capacity(immediately after product intake)
- Tmax of plasma glucose(between 0 and 3 hours post product intake)