Functional and Value-Added Dairy Products and Blood Glucose Control

October 17, 2023 updated by: Bohdan Luhovyy, Mount Saint Vincent University

The Sensory and Metabolic Effects of Functional and Value-Added Dairy Products

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3M 2J6
        • Mount Saint Vincent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chocolate milk
Chocolate milk with reduced added sugar
Dairy products with reduced sugar content
Experimental: Chocolate milk with whey protein
Chocolate milk with reduced added sugar and added whey protein
Dairy products with reduced sugar content
Experimental: Chocolate milk with casein
Chocolate milk with reduced added sugar and added casein
Dairy products with reduced sugar content
Experimental: Chocolate milk with alpha-lactalbumin
Chocolate milk with reduced added sugar and added alpha-lactalbumin
Dairy products with reduced sugar content
Experimental: Chocolate milk with glycomacropeptide
Chocolate milk with reduced added sugar and added glycomacropeptide
Dairy products with reduced sugar content

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose
Time Frame: 0-120 minutes
The concentration of blood glucose
0-120 minutes
Insulin
Time Frame: 0-120 minutes
The concentration of insulin
0-120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-peptide
Time Frame: 0-120 minutes
The concentration of C-peptide
0-120 minutes
Incretins, glucagon and amino acids
Time Frame: 0-120 minutes
The concentration of incretins and glucagon
0-120 minutes
Satiety
Time Frame: 0-120 minutes
The components of average subjective appetite including desire to eat, hunger, fullness, and a prospective food consumption measured with 100mm visual analogue scales.
0-120 minutes
Food Intake
Time Frame: 0 min, 120 minutes
Energy intake with an ad libitum meat at 120 minutes
0 min, 120 minutes
Thirst
Time Frame: 0-120 minutes
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).
0-120 minutes
Physical comfort
Time Frame: 0-120 minutes
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.
0-120 minutes
Food pleasantness
Time Frame: at 0 and 120 minutes
The perception of pleasantness of the treatments (0 minutes) and a test meal (at 120 minutes) will be measured with 100mm visual analogue scale.
at 0 and 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Bohdan Luhovyy, PhD, Mount Saint Vincent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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