Functional and Value-Added Dairy Products and Blood Glucose Control

Sponsor

Mount Saint Vincent University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05400694

Collaborator

University of Toronto (Other)

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Glucose, High Metabolic Disease Overweight and Obesity	Other: Food	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Masking Description:

Treatments are blinded.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Blood glucose [0-120 minutes]
The concentration of blood glucose
Insulin [0-120 minutes]
The concentration of insulin

Secondary Outcome Measures

C-peptide [0-120 minutes]
The concentration of C-peptide
Incretins, glucagon and amino acids [0-120 minutes]
The concentration of incretins and glucagon
Satiety [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.
Food Intake [0 min, 120 minutes]
Energy intake with an ad libitum meat at 120 minutes
Thirst [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).
Physical comfort [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.
Food pleasantness [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.