Effect of Ingestion of Human, Cow, and Modified-cow Milk, on Glucose and Hormone Responses in Humans.

Not Applicable

Completed

• Conditions: Insulin Tolerance; Hormone; Aminoacidaemia
• Interventions: Dietary Supplement: low protein cow milk; Dietary Supplement: natural human; Dietary Supplement: natural cow; Dietary Supplement: high protein cow milk

• Registration Number: NCT04698889
• Lead Sponsor: University of Padova

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-04-07
• Primary Completion: 2019-02-05
• Study Completion: 2020-10-01
• Study First Submitted: 2020-12-14
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-06
• Last Update Submitted: 2021-01-06
• Study First Posted: 2021-01-07
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Modified cow milk - low protein	low protein cow milk	Administration of modified cow milk at low protein content
Human milk	natural human	Administration of natural human milk
Cow milk	natural cow	Administration of natural cow whole milk
Modified cow milk - high protein	high protein cow milk	Administration of modified cow milk at high protein content

Primary Outcome Measures

Name	Time	Method
Plasma insulin and c-peptide	1 year	microunits and nanomoles
Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-1	1 year	picomol/L and picogram/mL

Secondary Outcome Measures

Name	Time	Method
Plasma Amino acids	2 years	micromol/L