search
Back to results

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

Primary Purpose

Hyperglycemia, Lack of Satiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Skim milk products
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperglycemia focused on measuring satiety, glycemia, milk protein

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of Guelph- Human Nutraceutical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Water Control

Skim Milk

High Protein Milk

High Protein Milk (Modified Ratio)

Skim Milk (Modified Ratio)

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)

Secondary Outcome Measures

Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)
Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)

Full Information

First Posted
May 26, 2015
Last Updated
October 24, 2016
Sponsor
University of Guelph
Collaborators
University of Toronto, Laval University
search

1. Study Identification

Unique Protocol Identification Number
NCT02471092
Brief Title
The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
Official Title
The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
University of Toronto, Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Lack of Satiety
Keywords
satiety, glycemia, milk protein

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water Control
Arm Type
Placebo Comparator
Arm Description
Skim milk products. Water and permeate control; 250mL serving.
Arm Title
Skim Milk
Arm Type
Active Comparator
Arm Description
Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving.
Arm Title
High Protein Milk
Arm Type
Experimental
Arm Description
Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving.
Arm Title
High Protein Milk (Modified Ratio)
Arm Type
Experimental
Arm Description
Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving.
Arm Title
Skim Milk (Modified Ratio)
Arm Type
Experimental
Arm Description
Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving.
Intervention Type
Other
Intervention Name(s)
Skim milk products
Intervention Description
Milk treatments will be served with 58g of breakfast cereal.
Primary Outcome Measure Information:
Title
Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)
Time Frame
0-200 minutes
Secondary Outcome Measure Information:
Title
Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)
Time Frame
0-200 minutes
Title
Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)
Time Frame
at 120 minutes
Other Pre-specified Outcome Measures:
Title
Hormone and Amino Acid Analysis, as measured by biochemical assay (pmol/L and nmol/mL)
Time Frame
0-200 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda J Wright, Ph.D.
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph- Human Nutraceutical Research Unit
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33024990
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs