- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04854603
Dairy Products With Reduced Sugar and Blood Glucose
March 14, 2023 updated by: Bohdan Luhovyy, Mount Saint Vincent University
The Effect of Dairy Products With Reduced Added Sugar Content on Blood Glucose, Satiety and Food Intake
Dairy products represent an important food group in human nutrition as a source of calcium, protein, functional fats and low-glycaemic sugar lactose.
While traditionally consumed natural milk and yogurt have low sugar content, many flavoured liquid dairy products such as chocolate milk, or fermented products such as yogurt have added sugar.
Our recent studies have shown that the partial reduction of added sugar in chocolate milk and yogurt is not associated with any inferior sensory characteristics such as taste and pleasantness compared to their full-sugar counterparts.
The current project will investigate whether the liquid dairy products with reduced sugar content (value-added products) have any benefits on blood glucose control in humans.
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
- Name: Bohdan Luhovyy, PhD
- Phone Number: 9024576256
- Email: bohdan.luhovyy@msvu.ca
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
Genders Eligible for Study
All
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chocolate milk with a regular added sugar content
Dairy product with a regular sugar content
|
Dairy products with regular and reduced sugar content and water control.
|
Experimental: Chocolate milk with a reduced added sugar content
Dairy product with a reduced sugar content
|
Dairy products with regular and reduced sugar content and water control.
|
Experimental: Yogurt with a regular added sugar content
Dairy product with a regular sugar content
|
Dairy products with regular and reduced sugar content and water control.
|
Experimental: Yogurt with a reduced added sugar content
Dairy product with a reduced sugar content
|
Dairy products with regular and reduced sugar content and water control.
|
Experimental: Energy-free control
Potable water
|
Dairy products with regular and reduced sugar content and water control.
|
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 blood glucose
|
0-120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 min) and a test meal (at 120 min) will be measured with 100mm visual analogue scale.
|
at 0 and 120 minutes
|
Food intake
Time Frame: 120 minutes
|
Energy intake with an ad libitum meat at 120 minutes
|
120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 2, 2021
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
August 31, 2022
Study Registration Dates
First Submitted
April 10, 2021
First Submitted That Met QC Criteria
April 21, 2021
First Posted (Actual)
April 22, 2021
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-202-01
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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