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

University of Guelph

Status: Completed

Conditions: Hyperglycemia; Lack of Satiety

Treatments: Other: Skim milk products

Study type: Interventional

Funder types: Other

Identifiers

NCT02471092

14JN004

Details and patient eligibility

About

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.

Full description

1. 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.
2. 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 5 patient groups, including a placebo group

Water Control

Placebo Comparator group

Description:

Skim milk products. Water and permeate control; 250mL serving.

Treatment:

Other: Skim milk products

Skim Milk

Active Comparator group

Description:

Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving.

Treatment:

Other: Skim milk products

High Protein Milk

Experimental group

Description:

Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving.

Treatment:

Other: Skim milk products

High Protein Milk (Modified Ratio)

Experimental group

Description:

Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving.

Treatment:

Other: Skim milk products

Skim Milk (Modified Ratio)

Experimental group

Description:

Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving.

Treatment:

Other: Skim milk products