- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05400694
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 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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-202-02
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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