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

University of Padova

Status: Completed

Conditions: Hormone; Insulin Tolerance; Aminoacidaemia

Treatments: Dietary Supplement: natural cow; Dietary Supplement: low protein cow milk; Dietary Supplement: high protein cow milk; Dietary Supplement: natural human

Study type: Interventional

Funder types: Other

Identifiers

NCT04698889

Tessari Protocol 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 4 patient groups

Cow milk

Active Comparator group

Description:

Administration of natural cow whole milk

Treatment:

Dietary Supplement: natural cow

Human milk

Active Comparator group

Description:

Administration of natural human milk

Treatment:

Dietary Supplement: natural human

Modified cow milk - low protein

Active Comparator group

Description:

Administration of modified cow milk at low protein content

Treatment:

Dietary Supplement: low protein cow milk

Modified cow milk - high protein

Active Comparator group

Description:

Administration of modified cow milk at high protein content

Treatment:

Dietary Supplement: high protein cow milk