Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04698889 |
Other study ID # |
Tessari Protocol 1 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 7, 2015 |
Est. completion date |
October 1, 2020 |
Study information
Verified date |
January 2021 |
Source |
University of Padova |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.