Gut Hormone Response After Two Paleolithic-type Meals Compared to a Modern-type Meal Composed According to WHO Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Glucagon-like peptide-1
研究概览
简要总结
The effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones, satiety, blood glucose and insulin levels as compared to a meal constructed along the lines of the world Health Organisation dietary recommendations
详细描述
In the current study the effects of two palaeolithic-type meals will be assessed with respect to a panel of gut hormones (including incretins), satiety, blood glucose and insulin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) 18-27 inclusive
- •Apparently healthy: no medical conditions which might affect study measurements as judged by Leatherhead physician based on a health questionnaire)
- •Having general practitioner
- •Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian
- •Reported intense sporting activities less than 10h/w
- •Reported alcohol consumption less than 21units/w
- •non-smoking
- •A fasting capillary blood glucose value within the local normal reference value: 4-6.5 mmol/L measured by finger prick
排除标准
- •Use of medication which interferes with the study measurements (as judged by the study physician)
- •Being an employee of Unilever or Leatherhead Food Research
- •Scoff questionaire score ≥ 2
- •Eating habit questionnaire ≥ 14
- •Dislike, allergy or intolerance t the test meals or the ad libitum meal
- •Reported participation in another nutritional or biomedical trial 3 months before pre-study examination or during the study
- •Reported participation in night shift work two weeks prior to the pre-study investigation during the study. Night work is defined as working between midnight and 06.00 AM
研究组 & 干预措施
PAL-2
Based on WHO dietary guidelines for protein, fat and carbohydrate but made with ingredients that would have been available in palaeolithic times (e.g. no cereals, no dairy).
干预措施: PAL-2 (Other)
TFH-1
Based on WHO dietary guidelines for protein, fat and carbohydrate but made with ingredients that would have been available in palaeolithic times, (e.g. no cereals, no dairy).
干预措施: TFH-1 (Other)
Reference
Meal based on WHO dietary guidelines for protein, fat and carbohydrate.
干预措施: Reference (Other)
结局指标
主要结局
Glucagon-like peptide-1
时间窗: 0-3 hours
Area under the Concentration versus time curve for Glucagon-like peptide-1 in blood plasma
次要结局
- Insulin(0-3 hours)
- Glucose-dependent Insulinotropic Peptide(0-3 hours)
- Fullness(0-4 hours)
- Glucose(0-3 hours)
- Glucagon(0-3 hours)
- Peptide YY(0-3 hours)
- Hunger(0-4 hours)
- Desire to eat(0-4 hours)