Thylakoids' Effect on Glucose Homeostasis and Appetite Regulation After an Oral Glucose Tolerance Test in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 21
- 主要终点
- Insulin sensitivity
研究概览
简要总结
This cross-over intervention study aims to investigate the effect of two doses of thylakoids to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as appetite regulating hormones in healthy volunteers.
详细描述
A minimum of twenty healthy volunteers are recruited to participate in an OGTT at three different occasions separated by one week. At two of the occasions a green leaf extract, thylakoids, is added to a glucose solution; 5 gram or 10 gram in randomized order. The third occasion, without added thylakoids, serve as control.
Blood samples are taken fasting and 15, 30, 45, 60, 90, 120 and 180 minutes after the glucose load.
Blood samples are analysed for p-glucose, p-insulin, p-C-peptide, p-ghrelin, p-CCK and p-GLP-1.
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
- Single (Participant)
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
- •Normal-weight and weight stable
- •Not pregnant or breast-feeding
- •No use of medication that can affect glucose- and insulin homeostasis (for example corticosteroids).
排除标准
- •Diabetes,
- •Impaired glucose tolerance and/or insulin resistance
- •Use of tobacco or drugs.
研究组 & 干预措施
Placebo comparator: Control
OGTT without thylakoids.
干预措施: Placebo Comparator: Control (Other)
Experimental: Thylakoids 5 g
Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion.
干预措施: Experimental: Thylakoids 5 g (Dietary Supplement)
Experimental: Thylakoids 10 g
Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 10 g. Intervention: OGTT at one occasion.
干预措施: Experimental: Thylakoids 10 g (Dietary Supplement)
结局指标
主要结局
Insulin sensitivity
时间窗: 180 minutes, repeated at three occasions
Measurement of p-glucose, p-insulin and p-C-peptide in repeated blood sampling during three hours after an OGTT.
次要结局
- p-GLP-1(180 minutes, repeated at three occasions)
- p-ghrelin(180 minutes, repeated at three occasions)