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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471092
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : October 25, 2016
Sponsor:
Collaborators:
University of Toronto
Laval University
Information provided by (Responsible Party):
Amanda Wright, Ph.D., 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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Lack of Satiety Other: Skim milk products Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
Study Start Date : November 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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.




Primary Outcome Measures :
  1. Postprandial Glycemia, as measured by capillary blood glucose (mmol/L) [ Time Frame: 0-200 minutes ]

Secondary Outcome Measures :
  1. Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm) [ Time Frame: 0-200 minutes ]
  2. Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g) [ Time Frame: at 120 minutes ]

Other Outcome Measures:
  1. Hormone and Amino Acid Analysis, as measured by biochemical assay (pmol/L and nmol/mL) [ Time Frame: 0-200 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471092


Locations
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Canada, Ontario
University of Guelph- Human Nutraceutical Research Unit
Guelph, Ontario, Canada, N1G2W1
Sponsors and Collaborators
University of Guelph
University of Toronto
Laval University
Investigators
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Principal Investigator: Amanda J Wright, Ph.D. University of Guelph
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Responsible Party: Amanda Wright, Ph.D., Associate Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT02471092    
Other Study ID Numbers: 14JN004
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Keywords provided by Amanda Wright, Ph.D., University of Guelph:
satiety
glycemia
milk protein
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases