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

NCT ID: NCT04698889

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-07
• Study Completion Date: 2020-10-01

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.

Conditions

Insulin Tolerance; Hormone; Aminoacidaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cow milk

Administration of natural cow whole milk

Group Type: ACTIVE_COMPARATOR

natural cow

Intervention Type: DIETARY_SUPPLEMENT

Human milk

Administration of natural human milk

Group Type: ACTIVE_COMPARATOR

natural human

Intervention Type: DIETARY_SUPPLEMENT

Modified cow milk - low protein

Administration of modified cow milk at low protein content

Group Type: ACTIVE_COMPARATOR

low protein cow milk

Intervention Type: DIETARY_SUPPLEMENT

Modified cow milk - high protein

Administration of modified cow milk at high protein content

Group Type: ACTIVE_COMPARATOR

high protein cow milk

Intervention Type: DIETARY_SUPPLEMENT

Interventions

natural cow

Intervention Type: DIETARY_SUPPLEMENT

high protein cow milk

Intervention Type: DIETARY_SUPPLEMENT

natural human

Intervention Type: DIETARY_SUPPLEMENT

low protein cow milk

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Tessari Paolo

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Tessari Protocol 1

Identifier Type: -

Identifier Source: org_study_id