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Completed

NCT Number: NCT04698889

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

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Key information

Conditions

Insulin Tolerance Aminoacidaemia Hormone

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

natural cow

Dietary Supplement

high protein cow milk

Dietary Supplement

natural human

Dietary Supplement

low protein cow milk

Dietary Supplement

Primary outcomes

  1. Plasma insulin and c-peptide

    Time frame: 1 year

    microunits and nanomoles

  2. Plasma GIP: glucose-inhibitory polypeptide and GLP-1: glucagon-like-polypeptide-1

    Time frame: 1 year

    picomol/L and picogram/mL

Secondary outcomes

  1. Plasma Amino acids

    Time frame: 2 years

    micromol/L

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Acronym: PROLAT

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jan 7, 2021
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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