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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hormone, Insulin Tolerance, Aminoacidaemia

Intervention / Treatment
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* Dietary Supplement: natural cow
* Dietary Supplement: high protein cow milk
* Dietary Supplement: natural human
* Dietary Supplement: low protein cow milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Subjects allocated to receive one or more milk types in random order on different occasions, spaced by at least two weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cow milk<br>Administration of natural cow whole milk | Dietary Supplement: natural cow<br> <br> |
| Active Comparator: Human milk<br>Administration of natural human milk | Dietary Supplement: natural human<br> <br> |
| Active Comparator: Modified cow milk - low protein<br>Administration of modified cow milk at low protein content | Dietary Supplement: low protein cow milk<br> <br> |
| Active Comparator: Modified cow milk - high protein<br>Administration of modified cow milk at high protein content | Dietary Supplement: high protein cow milk<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Amino acids | micromol/L | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cow milk, human milk, incretins, casein, whey proteins