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

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

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.

Study Overview

• Status: Completed
• Conditions: Hormone; Insulin Tolerance; Aminoacidaemia
• Intervention / Treatment: Dietary supplement: natural cow; Dietary supplement: natural human; Dietary supplement: low protein cow milk; Dietary supplement: high protein cow milk

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cow milk; Administration of natural cow whole milk	Dietary supplement: natural cow
Active Comparator: Human milk; Administration of natural human milk	Dietary supplement: natural human
Active Comparator: Modified cow milk - low protein; Administration of modified cow milk at low protein content	Dietary supplement: low protein cow milk
Active Comparator: Modified cow milk - high protein; Administration of modified cow milk at high protein content	Dietary supplement: high protein cow milk

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Amino acids	micromol/L	2 years

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2015
• Primary Completion (Actual): February 5, 2019
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: incretins; human milk; casein; cow milk; whey proteins
• Other Study ID Numbers: Tessari Protocol 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No