Metabolic Effects of a Pre-meal Protein Drink With or Without Added Amino Acids at a Subsequent Composite Meal

Study Overview
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Brief Summary
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The purpose of the study was to investigate the efficacy of intake of whey or soy protein isolates, respectively, with or without supplementation of amino acids, on post-meal insulin secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut hormones and ghrelin in plasma, as well as subjective satiety was investigated.

Detailed Description
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Hyperglycaemia in type 2 diabetes (T2D) is associated with an increased risk of cardiovascular diseases, and it has been suggested that reduction of postprandial glycaemia is just as important as lowering fasting blood glucose levels to reach optimal metabolic control and reduce risk of complications in T2D. Observational studies indicate that milk consumption reduces the risk of developing T2D, obesity and cardiovascular disease, and a possible protective mechanism has been ascribed to the protein fraction. It has previously been demonstrated that addition of whey proteins, co-ingested with carbohydrates, stimulates insulin secretion and reduces postprandial glycaemia in both healthy subjects as well as in T2D patients. The effect is mediated through the insulinogenic properties of whey that appears to stem from a generation of a particular amino acid (AA) pattern in postprandial blood after ingestion of whey proteins. In the presently described project it is hypothesized that exchanging part of the whey protein for insulinogenic AA might be useful to optimize an insulinogenic effect. Additionally, soy protein has been suggested to have beneficial effects on insulin resistance and obesity as well on satiety. The possible effect of soy protein on insulin response and glycaemic regulation is therefore also of interest. A randomized, single blind, within-subject trial was performed. The test meals were provided as breakfasts on 7 different occasions in random order with approximately 1 week between each test. The test subjects were instructed to drink the protein drink immediately prior to eating the standardized sandwich meal. Altogether, the protein drink and the sandwich meal were to be consumed within 12 min.

Official Title
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Effects of Pre-meal Drinks With Protein and Amino Acids on Glycemic and Metabolic Responses at a Subsequent Composite Meal

Conditions
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Diabetes Mellitus, Type 2, Satiety Response

Intervention / Treatment
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* Dietary Supplement: Protein drink
* Dietary Supplement: Reference meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normal fasting blood glucose normal BMI Exclusion Criteria: smokers vegetarians subjects who receives any drug treatment lactose malabsorption

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 28 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reference meal<br> | Dietary Supplement: Reference meal<br>* Control meal<br>|
| Experimental: Whey protein<br> | Dietary Supplement: Protein drink<br>* Test drink providing 9g protein<br>|
| Experimental: Whey + 5 amino acids<br> | Dietary Supplement: Protein drink<br>* Test drink providing 9g protein<br>|
| Experimental: Whey + 6 amino acids<br> | Dietary Supplement: Protein drink<br>* Test drink providing 9g protein<br>|
| Experimental: Soy protein drink<br> | Dietary Supplement: Protein drink<br>* Test drink providing 9g protein<br>|
| Experimental: Soy + 5 amino acids<br> | Dietary Supplement: Protein drink<br>* Test drink providing 9g protein<br>|
| Experimental: Soy + 6 amino acids<br> | Dietary Supplement: Protein drink<br>* Test drink providing 9g protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose, insulin, amino acids, ghrelin and incretins |  | Acute postprandial phase (0-180 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective satiety |  | 3h postprandial (0-180 min) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whey protein, Soy protein, Insulinogenic amino acids, Incretins, Glycaemia, Insulinaemia