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

Not Applicable

Completed

• Conditions: Hyperglycemia; Lack of Satiety
• Interventions: Other: Skim milk products

• Registration Number: NCT02471092
• Lead Sponsor: University of Guelph

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-15
• Primary Completion: 2015-10
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Water Control	Skim milk products	Skim milk products. Water and permeate control; 250mL serving.
Skim Milk	Skim milk products	Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving.
High Protein Milk	Skim milk products	Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving.
High Protein Milk (Modified Ratio)	Skim milk products	Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving.
Skim Milk (Modified Ratio)	Skim milk products	Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving.

Primary Outcome Measures

Name	Time	Method
Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)	0-200 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Guelph- Human Nutraceutical Research Unit; 🇨🇦 Guelph, Ontario, Canada