Functional and Value-Added Dairy Products and Blood Glucose Control

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05400694
• Other study ID #: 2019-202-02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2023
• Source: Mount Saint Vincent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Glucose, High
• Metabolic Disease
• Metabolic Diseases
• Overweight
• Overweight and Obesity

Intervention

Other:
• Food
Dairy products with reduced sugar content

Locations

Country	Name	City	State
Canada	Mount Saint Vincent University	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Mount Saint Vincent University	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	The concentration of blood glucose	0-120 minutes
Primary	Insulin	The concentration of insulin	0-120 minutes
Secondary	C-peptide	The concentration of C-peptide	0-120 minutes
Secondary	Incretins, glucagon and amino acids	The concentration of incretins and glucagon	0-120 minutes
Secondary	Satiety	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
Secondary	Food Intake	Energy intake with an ad libitum meat at 120 minutes	0 min, 120 minutes
Secondary	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).	0-120 minutes
Secondary	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.	0-120 minutes
Secondary	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.	at 0 and 120 minutes