Randomized, Controlled, Cross-over Study Comparing The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- area under the curve (AUC) for glucose and insulin
研究概览
简要总结
The objective of this trial is to compare a snack with ingredients (whole grains and dietary fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and evaluate the effect of the snack on glycemic response and subjective satiety. The test product will be compared with a control product as well as white bread in a randomized, controlled, crossover trial including 20 healthy males or females between the ages of 18 and 70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast, participants will be given each of the study products in a random order at least a week apart. Glucose and insulin will be measured before product consumption and over a period of four hours. Visual analog scales to measure subjective satiety will also be administered over a period of four hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females between the ages of 18 and 70 inclusive
- •No chronic medications other than oral contraceptives
- •Body Mass Index (BMI) between 25 and 30 kg/m2 inclusive.
- •Body weight stable in a 5 kg range in the 3 months prior to study entry
排除标准
- •Pregnant or nursing a baby
- •Women with child-bearing potential who are unwilling to use an effective means of contraception during the study which could include abstinence.
- •Adults unable to consent and prisoners
研究组 & 干预措施
Test-cluster
56g of optimized savory cluster made through a proprietary process with slowly digestible carbohydrates and fiber
干预措施: Nutrient cluster (Other)
Control-cluster
56g of control cluster made from general baking process with typical ingredients commonly used in commercially available energy snacks or bars
干预措施: Nutrient cluster (Other)
White-bread
45g of white bread containing equivalent amount of available carbohydrate in 56g of optimized savory cluster
干预措施: Nutrient cluster (Other)
结局指标
主要结局
area under the curve (AUC) for glucose and insulin
时间窗: 0-4 hours post consumption
次要结局
- AUC for the visual analog scale (VAS) ratings of satiety(0-4 hours post consumption)