Metabolic Effects of cGMP: From Amino Acid Absorption Kinetics to Appetite Modulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
研究概览
简要总结
Phenylketonuria is an inborn error of phenylalanine metabolism. Although the phenylalanine-restricted diet is recognized as the mainstay of therapy, little is known about the impact of protein substitutes on the metabolism of patients with phenylketonuria.
Therefore, the aim of this project is to study the impact of acute ingestion of casein glycomacropeptide supplemented with amino acids (cCGMP-AAs) alone or in combination with two different meals on amino acid absorption kinetics, glycaemic and insulinemic response, and on acute markers of appetite control.
The main findings of this project will bring new insights into the dietary management of these patients, which may lead to improvements in protein substitutes formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •Adults (age ≥ 18 years)
- •Body Mass Index (BMI) between 18.5-25.0 kg/m2
- •Filling informed consent
排除标准
- •Clinically significant illness
- •Have changed frequency, duration, or intensity of physical activity in the last month
- •Taking protein supplements
- •Pregnant or breastfeeding
- •Smoking and drug use
研究组 & 干预措施
Meal A
Meal A - CGMP-AAs alone
干预措施: cGMP-AAs alone (20 g of protein equivalent) (Dietary Supplement)
Meal B
Meal B - CGMP-AAs in combination with carbohydrates (including fibre)
干预措施: cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 160 g of unpeeled apple (Dietary Supplement)
Meal C
Meal C - CGMP-AAs in combination with carbohydrates and fat
干预措施: cGMP-AAs (20 g of protein equivalent) + 50 g of low-protein bread + 10 g of olive oil (Dietary Supplement)
结局指标
主要结局
Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
时间窗: 180 minutes
GLP-1 will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L\*min) for GLP-1 will be calculated based on the concentration curve following consumption of the test meal.
Changes in the iAUC (pmol/L*min) for Gastric inhibitory polypeptide (GIP)
时间窗: 180 minutes
GIP will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L\*min) for GIP will be calculated based on the concentration curve following consumption of the test meal.
Changes in the iAUC (mmol/L*min) for total amino acids
时间窗: 180 minutes
Total amino acids will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (mmol/L\*min) for amino acids will be calculated based on the concentration curve following consumption of the test meal.
Changes in the iAUC (pmol/L*min) for Cholecystokinin (CCK)
时间窗: 180 minutes
CCK will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L\*min) for CCK will be calculated based on the concentration curve following consumption of the test meal.
Changes in the iAUC (pmol/L*min) for peptide YY (PYY)
时间窗: 180 minutes
PYY will be measured in fasting and every 30 minutes up to 180 minutes. The iAUC (pmol/L\*min) for PYY will be calculated based on the concentration curve following consumption of the test meal.
次要结局
- Changes in glucose(180 minutes)
- Changes in C-peptide(180 minutes)
- Changes in insulin(180 minutes)