Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- plasma insulin
研究概览
简要总结
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions:
- blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
- blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the concentrations seen during oral consumption.
The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes after 3-OHB consumed orally vs. intravenously.
Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg Paracetamol consumption before each intervention day. Urine will be analyzed for ketone concentrations/excretion rates.
详细描述
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions with at least 48 hours apart.
- blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
- blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the concentrations seen during oral consumption.
The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes after 3-OHB consumed orally vs. intravenously.
Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg Paracetamol consumption before each intervention day. Urine will be analyzed for ketone concentrations/excretion rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19<BMI<30
- •written og oral consent
- •No allergies to paracetamol
排除标准
- •Chronic disease or daily medical treatment
- •Daily intake of ketones or ketogenic diets
- •Speaks and understands Danish
- •Screening blood sample abnormalities
结局指标
主要结局
plasma insulin
时间窗: 180 minutes
incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l}
次要结局
- Plasma PYY(180 minutes)
- height(at time 0 minutes)
- Ad libitum food intake(at time = 180 minutes)
- Plasma Glucagon(180 minutes)
- Gastric emptying(180 minutes)
- Urine 3-OHB(180 minutes)
- Plasma GLP1(180 minutes)
- Plasma GIP(180 minutes)
- Plasma free fatty acids(180 minutes)
- Blood pressure(time 0 minutes and 180 minutes)
- Plasma glucose(180 minutes)
- Plasma 3-OHB(180 minutes)
- weight(at time 0 minutes)
- BMI(time 0 minutes)
- Satiety questionnaire (Blundell et al. 2010)(At 0, 60, 120, and 180 minutes)
- Plasma Ghrelin(180 minutes)
研究者
Nikolaj Fibiger Rittig
Principal investigator, MD, PhD, and clinical researcher
University of Aarhus