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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cow milk | Active Comparator | Administration of natural cow whole milk |
|
| Human milk | Active Comparator | Administration of natural human milk |
|
| Modified cow milk - low protein | Active Comparator | Administration of modified cow milk at low protein content |
|
| Modified cow milk - high protein | Active Comparator | Administration of modified cow milk at high protein content |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natural cow | Dietary Supplement |
| ||
| high protein cow milk |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Amino acids | micromol/L | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2015 | Dec 30, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 12, 2015 | Dec 30, 2020 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2015 | Dec 30, 2020 | ICF_002.pdf |
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Subjects allocated to receive one or more milk types in random order on different occasions, spaced by at least two weeks
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|
| natural human | Dietary Supplement |
|
| low protein cow milk | Dietary Supplement |
|