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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Lack of Satiety
• Intervention / Treatment: Other: Skim milk products

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G2W1
      • University of Guelph- Human Nutraceutical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Hormone and Amino Acid Analysis, as measured by biochemical assay (pmol/L and nmol/mL)	0-200 minutes

Collaborators and Investigators

• Sponsor: University of Guelph
• Collaborators: University of Toronto; Laval University
• Investigators: Principal Investigator: Amanda J Wright, Ph.D., University of Guelph

Publications and helpful links

General Publications

• Kung B, Turgeon SL, Vien S, Kubant R, El Khoury D, Wright AJ, Goff HD, Anderson GH. Role of Amino Acids in Blood Glucose Changes in Young Adults Consuming Cereal with Milks Varying in Casein and Whey Concentrations and Their Ratio. J Nutr. 2020 Dec 10;150(12):3103-3113. doi: 10.1093/jn/nxaa275.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: satiety; glycemia; milk protein
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 14JN004