Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference in mean insulin concentration
研究概览
简要总结
To investigate whether there is a linear dose-response relationship between oral lactate and its effects on gut hormone secretion, motility, and appetite.
Hypothesis Oral lactate administration affects gut hormone secretion, insulin levels, motility, appetite sensation and the amount of food intake in a linear dose-response relationship.
详细描述
The participants will meet up fasting at the Steno Diabetes Centre Aarhus Research Lab. Immediately after arrival, they will be placed in a bed. The four trial days will be completely alike, besides the interventions.
The participants will have one intravenous (iv.) access placed in the elbow on the four trial days for a continuous drawing of blood samples throughout the trial day.
Before drinking the intervention, baseline blood samples will be drawn. Immediately after drinking the intervention, the participants will take 1500 mg paracetamol to determine ventricular emptying rate through the acetaminophen test.
After this, the participants can lay in their bed and watch TV, Ipad or work on their computer. Blood samples will be collected at 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes after the intervention. Appetite sensations will be measured by a visual analog scales (VAS). After 3 hours the trial day is finished, and the participants can go home.
Before and after each trial day the participants will collect a fecal sample.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years
- •Written and oral consent
排除标准
- •HbA1c > 39
- •Taking medicine
- •Any diseases
- •Allergy to paracetamol
- •Doesn't speak or understand Danish.
- •Special diets
结局指标
主要结局
Difference in mean insulin concentration
时间窗: 60 minutes
Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20.
次要结局
- Difference in LEAP2(0-180 minutes after the intervention)
- Difference in blood glucose(0-180 minutes after the intervention)
- Difference in GLP-1(0-180 minutes after the intervention)
- Difference in GIP(0-180 minutes after the intervention)
- Difference in glucagon(0-180 minutes after the intervention)
- Difference in c-peptide(0-180 minutes after the intervention)
- Difference in gastric emptying rate(0-180 minutes after the intervention)
- Difference in appetite sensation(0-180 minutes)
研究者
Jens Hohwü Voigt
MD, PhD student
University of Aarhus