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临床试验/NCT04698889
NCT04698889已完成不适用

Study of the Effects of Ingestion of Natural Human, Natural Cow, and Modified-cow Milk, on Glucose, Amino Acids, Insulin, and Incretin Responses in Humans

University of Padova0 个研究点目标入组 17 人开始时间: 2015年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
主要终点
Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-1

研究概览

简要总结

Human milk, despite a much lower protein content, is as effective as cow milk on insulin stimulation under iso-lactose conditions. The causes for such a similar potency are unknown. This effect could be due to incretin and amino-acid responses, and/or to milk-protein interactions.In this study the investigators will address the above question(s) by testing, in young healthy volunteers, the effects of natural cow and human milk, as well as of the manipulation of the casein and whey protein content in cow milk, on insulin, C-peptide, GLP-1 and GIP secretion, as well as on circulating amino acids.

详细描述

Objective

To determine plasma glucose, insulin, C-peptide, glucagon-like polypeptide-1 (GLP-1), glucose-inhibitory-polypeptide (GIP) and amino-acid responses, following administration of human and cow milk, either natural or with experimentally-modified casein and whey-protein content(s).

Design. Young healthy volunteers of both sexes will receive iso-lactose loads (0.36 g lactose / kg body weight) of: natural cow milk; natural human milk; and of cow milk with modified casein and whey protein contents. Blood samples will be frequently collected over 4 hours. Plasma glucose, amino acids, insulin and incretin concentrations will be measured.

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
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-35 yrs
  • Both sexes
  • In post-absorptive state
  • Hemoglobin Hb1c values within normal values.
  • Previous regular, moderate physical activity
  • Stable body weight and regular dietary habits.

排除标准

  • Familial or personal history of diabetes.
  • Altered fasting glucose and/ or impaired glucose tolerance.
  • Any metabolic, hormonal, hepatic, renal, and cardiovascular disease.
  • Current drug treatments

结局指标

主要结局

Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-1

时间窗: 1 year

picomol/L and picogram/mL

Plasma insulin and c-peptide

时间窗: 1 year

microunits and nanomoles

次要结局

  • Plasma Amino acids(2 years)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tessari Paolo

Professor, MD

University of Padova

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