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临床试验/NCT06794515
NCT06794515尚未招募不适用

Metabolic Effects of cGMP: From Amino Acid Absorption Kinetics to Appetite Modulation

Universidade Nova de Lisboa2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年2月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
试验地点
2
主要终点
Changes in the iAUC (mmol/L*min) for total amino acids

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

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

结局指标

主要结局

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 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 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.

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.

次要结局

  • Changes in glucose(180 minutes)
  • Changes in insulin(180 minutes)
  • Changes in C-peptide(180 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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