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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04698889
Acronym
PROLAT
Enrollment
17
Registered
2021-01-07
Start date
2015-04-07
Completion date
2020-10-01
Last updated
2021-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aminoacidaemia, Hormone, Insulin Tolerance

Keywords

cow milk, human milk, incretins, casein, whey proteins

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.

Interventions

DIETARY_SUPPLEMENTnatural cow
DIETARY_SUPPLEMENThigh protein cow milk
DIETARY_SUPPLEMENTnatural human
DIETARY_SUPPLEMENTlow protein cow milk

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma insulin and c-peptide1 yearmicrounits and nanomoles
Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-11 yearpicomol/L and picogram/mL

Secondary

MeasureTime frameDescription
Plasma Amino acids2 yearsmicromol/L

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026