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

NCT04698889 | Completed DMC

• 1 other identifier: Tessari Protocol 1
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insulin Tolerance; Hormone; Aminoacidaemia

Keywords

cow milk; human milk; incretins; casein; whey proteins

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Plasma Amino acids

  2 years

Study Arms (4)

Cow milk

ACTIVE COMPARATOR

Administration of natural cow whole milk

Dietary Supplement: natural cow

Human milk

ACTIVE COMPARATOR

Administration of natural human milk

Dietary Supplement: natural human

Modified cow milk - low protein

ACTIVE COMPARATOR

Administration of modified cow milk at low protein content

Dietary Supplement: low protein cow milk

Modified cow milk - high protein

ACTIVE COMPARATOR

Administration of modified cow milk at high protein content

Dietary Supplement: high protein cow milk

Interventions

natural cow DIETARY_SUPPLEMENT

Cow milk

high protein cow milk DIETARY_SUPPLEMENT

Modified cow milk - high protein

natural human DIETARY_SUPPLEMENT

Human milk

low protein cow milk DIETARY_SUPPLEMENT

Modified cow milk - low protein

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: Subjects allocated to receive one or more milk types in random order on different occasions, spaced by at least two weeks

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 7, 2021
• Study Start: April 7, 2015
• Primary Completion: February 5, 2019
• Study Completion: October 1, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share