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Functional and Value-Added Dairy Products and Blood Glucose Control

Primary Purpose

Blood Glucose, High, Metabolic Disease, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Food
Sponsored by
Mount Saint Vincent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Glucose, High focused on measuring Sugar intake, Sweeteners, Milk Proteins, Diabetes, Obesity, Sweetened food products, Chocolate milk, Blood glucose, Insulin, Satiety, Food Intake, Casein, Whey protein

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 19-35 y males and females, non-smokers

Exclusion Criteria:

  • having any diseases, irregular menses in females, smoking (all types), taking medications known to influence blood glucose control, skipping breakfast, and having emotional, or learning problems that would affect their ability to participate in the study as required. Individuals with known food allergies and lactose intolerance will be also excluded.

Sites / Locations

  • Mount Saint Vincent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Chocolate milk

Chocolate milk with whey protein

Chocolate milk with casein

Chocolate milk with alpha-lactalbumin

Chocolate milk with glycomacropeptide

Arm Description

Chocolate milk with reduced added sugar

Chocolate milk with reduced added sugar and added whey protein

Chocolate milk with reduced added sugar and added casein

Chocolate milk with reduced added sugar and added alpha-lactalbumin

Chocolate milk with reduced added sugar and added glycomacropeptide

Outcomes

Primary Outcome Measures

Blood glucose
The concentration of blood glucose
Insulin
The concentration of insulin

Secondary Outcome Measures

C-peptide
The concentration of C-peptide
Incretins, glucagon and amino acids
The concentration of incretins and glucagon
Satiety
The components of average subjective appetite including desire to eat, hunger, fullness, and a prospective food consumption measured with 100mm visual analogue scales.
Food Intake
Energy intake with an ad libitum meat at 120 minutes
Thirst
The subjective perception of thirst measured with 100mm visual analogue scales containing the question "How thirsty do you feel?" and two statements on each pole of 100mm line: "Not thirsty at all" (0mm) and "As thirsty as I have ever felt" (100mm).
Physical comfort
The subjective feeling of wellness and gastrointestinal discomfort parameters including the feeling of nausea, stomach cramps, flatulency, diarrhea and a subjective feeling of wellness, each measured with 100mm visual analogue scales.
Food pleasantness
The perception of pleasantness of the treatments (0 minutes) and a test meal (at 120 minutes) will be measured with 100mm visual analogue scale.

Full Information

First Posted
May 26, 2022
Last Updated
October 17, 2023
Sponsor
Mount Saint Vincent University
Collaborators
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05400694
Brief Title
Functional and Value-Added Dairy Products and Blood Glucose Control
Official Title
The Sensory and Metabolic Effects of Functional and Value-Added Dairy Products
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Saint Vincent University
Collaborators
University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Milk proteins possess multiple biological activities including their effect on blood glucose control, satiety and energy intake. The design of functional food products with added milk protein fractions has many challenges related to their inferior sensory properties. Chocolate milk presents the universal vehicle for added milk protein fractions that might partially mask their sensory characteristics. However, commercially produced chocolate milk has a significant amount of added sugar. This project will investigate the properties of a value-added dairy product (chocolate milk with reduced sugar content) enriched with individual milk protein fractions on characteristics of blood glucose control, satiety and energy intake in young healthy adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Glucose, High, Metabolic Disease, Overweight and Obesity
Keywords
Sugar intake, Sweeteners, Milk Proteins, Diabetes, Obesity, Sweetened food products, Chocolate milk, Blood glucose, Insulin, Satiety, Food Intake, Casein, Whey protein

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Treatments are blinded.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chocolate milk
Arm Type
Experimental
Arm Description
Chocolate milk with reduced added sugar
Arm Title
Chocolate milk with whey protein
Arm Type
Experimental
Arm Description
Chocolate milk with reduced added sugar and added whey protein
Arm Title
Chocolate milk with casein
Arm Type
Experimental
Arm Description
Chocolate milk with reduced added sugar and added casein
Arm Title
Chocolate milk with alpha-lactalbumin
Arm Type
Experimental
Arm Description
Chocolate milk with reduced added sugar and added alpha-lactalbumin
Arm Title
Chocolate milk with glycomacropeptide
Arm Type
Experimental
Arm Description
Chocolate milk with reduced added sugar and added glycomacropeptide
Intervention Type
Other
Intervention Name(s)
Food
Intervention Description
Dairy products with reduced sugar content
Primary Outcome Measure Information:
Title
Blood glucose
Description
The concentration of blood glucose
Time Frame
0-120 minutes
Title
Insulin
Description
The concentration of insulin
Time Frame
0-120 minutes
Secondary Outcome Measure Information:
Title
C-peptide
Description
The concentration of C-peptide
Time Frame
0-120 minutes
Title
Incretins, glucagon and amino acids
Description
The concentration of incretins and glucagon
Time Frame
0-120 minutes
Title
Satiety
Description
The components of average subjective appetite including desire to eat, hunger, fullness, and a prospective food consumption measured with 100mm visual analogue scales.
Time Frame
0-120 minutes
Title
Food Intake
Description
Energy intake with an ad libitum meat at 120 minutes
Time Frame
0 min, 120 minutes
Title
Thirst
Description
The subjective perception of thirst measured with 100mm visual analogue scales containing the question "How thirsty do you feel?" and two statements on each pole of 100mm line: "Not thirsty at all" (0mm) and "As thirsty as I have ever felt" (100mm).
Time Frame
0-120 minutes
Title
Physical comfort
Description
The subjective feeling of wellness and gastrointestinal discomfort parameters including the feeling of nausea, stomach cramps, flatulency, diarrhea and a subjective feeling of wellness, each measured with 100mm visual analogue scales.
Time Frame
0-120 minutes
Title
Food pleasantness
Description
The perception of pleasantness of the treatments (0 minutes) and a test meal (at 120 minutes) will be measured with 100mm visual analogue scale.
Time Frame
at 0 and 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 19-35 y males and females, non-smokers Exclusion Criteria: having any diseases, irregular menses in females, smoking (all types), taking medications known to influence blood glucose control, skipping breakfast, and having emotional, or learning problems that would affect their ability to participate in the study as required. Individuals with known food allergies and lactose intolerance will be also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bohdan Luhovyy, PhD
Organizational Affiliation
Mount Saint Vincent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Saint Vincent University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3M 2J6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional and Value-Added Dairy Products and Blood Glucose Control

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