Glycemic Response to an Innovative Cookie to Promote Human Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Glucose response
研究概览
简要总结
The aim of this study is to investigate whether using a coarse wheat fraction in wire-cut cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.
详细描述
This study has a double-blind, randomized, cross-over design. During each of the two study visits, healthy participants will consume a standard portion of cookies. One cookie formulation will present a large amount of coarse wheat fraction, while the other formulation will include only wheat flour and will serve as a control. Blood glucose measurements will be taken postprandially at regular time points. Gastric emptying rate and oral processing behavior will be also object of study.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) range 18.5 - 25.0 kg/m2 at screening visit
- •Fasting whole blood glucose values < 6.3 mmol/L
- •Regular diet with 3 meals a day (at least 5 times a week)
- •Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigators on the basis of medical history
- •Willingness to maintain habitual diet, physical activity pattern, and body weight throughout the trial
- •Willingness to abstain from alcohol consumption and to avoid vigorous physical activity for 24 h prior to study visits
- •Adequate level of understanding spoken and written English
- •Willingness to report lifestyle factors such as level of physical activity and perceived psychological stress
- •Willingness to provide informed consent to participate in the study
排除标准
- •Failure to meet any one of the inclusion criteria
- •Recent participation in any clinical trial (< 90 days)
- •Pregnant or lactating or wishing to become pregnant in the period of the study
- •Known history of AIDS, hepatitis, diabetes mellitus (Type I and II), cardiovascular disease, any pathology (or recent surgical event) of the gastrointestinal system or any current metabolic or endocrine disease
- •Alcohol consumption of > 14 standard drinks for women and > 21 standard drinks for men per week
- •Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period
- •Celiac disease or gluten intolerance
- •Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids the last 4 weeks before the screening visit
- •Use of antibiotics during the last three months
- •Reported slimming or medically prescribed diet
- •Unwillingness or inability to comply with the experimental procedures and to follow the safety guidelines
结局指标
主要结局
Glucose response
时间窗: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2
Incremental area under the curve of blood glucose concentration (mM) after wheat-based wire-cut cookie consumption, measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).
次要结局
- Oral processing behavior (average chews per bite)(During test meal consumption, up to 10 minutes, on test day 2)
- Peak rise of blood glucose(10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2)
- Oral processing behavior (exposure time)(During test meal consumption, up to 10 minutes, on test day 2)
- Oral processing behavior (energy intake rate)(During test meal consumption, up to 10 minutes, on test day 2)
- Gastric emptying rate(0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 2)
- Oral processing behavior (average bite size)(During test meal consumption, up to 10 minutes, on test day 2)
- Oral processing behavior (eating rate)(During test meal consumption, up to 10 minutes, on test day 2)