The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood

Study Overview
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Brief Summary
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The purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.

Detailed Description
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A total of 33 males and females will participate in the study. Capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study. Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.

Official Title
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The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood

Conditions
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Hyperglycemia, Lack of Satiety

Intervention / Treatment
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* Other: Skim milk products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 20 - 24.9 kg/m2 Healthy as determined by screening questionnaire Male or Female Non-smoking Normal fasting plasma glucose (<5.5 mmol/L), but not below 3.3 mmol/L. Prior use of acetaminophen Exclusion Criteria: Gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD) Weight loss or weight gain of more than 5 kg during the previous 2 months Taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid) Serious medical condition (ie. Renal, liver) Lack of appetite or skipping breakfast Restrained eaters as defined as having a Three Factor Eating Questionnaire-Cognitive Restraint >16 Smoking Reported intolerance to milk or very low consumption (< 2 servings per week) as assessed by in-person screening. Or not liking of the research foods. Food allergies or intolerances as well as anaphylactic or life-threatening allergies - food or otherwise Diabetes or other metabolic diseases that could interfere with study outcomes Acetaminophen, codeine or opioid allergy Pregnant or Breast Feeding Typical alcohol consumption of not more than 4 drinks per sitting

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water Control<br>Skim milk products. Water and permeate control; 250mL serving. | Other: Skim milk products<br>* Milk treatments will be served with 58g of breakfast cereal.<br>|
| Active Comparator: Skim Milk<br>Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving. | Other: Skim milk products<br>* Milk treatments will be served with 58g of breakfast cereal.<br>|
| Experimental: High Protein Milk<br>Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving. | Other: Skim milk products<br>* Milk treatments will be served with 58g of breakfast cereal.<br>|
| Experimental: High Protein Milk (Modified Ratio)<br>Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving. | Other: Skim milk products<br>* Milk treatments will be served with 58g of breakfast cereal.<br>|
| Experimental: Skim Milk (Modified Ratio)<br>Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving. | Other: Skim milk products<br>* Milk treatments will be served with 58g of breakfast cereal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glycemia, as measured by capillary blood glucose (mmol/L) |  | 0-200 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm) |  | 0-200 minutes | 
| Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g) |  | at 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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satiety, glycemia, milk protein