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Completed

NCT Number: NCT05400694

Functional and Value-Added Dairy Products and Blood Glucose Control

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.

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Key information

Conditions

Blood Glucose, High Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Disease Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food

Other

Dairy products with reduced sugar content

Primary outcomes

  1. Blood glucose

    Time frame: 0-120 minutes

    The concentration of blood glucose

  2. Insulin

    Time frame: 0-120 minutes

    The concentration of insulin

Secondary outcomes

  1. C-peptide

    Time frame: 0-120 minutes

    The concentration of C-peptide

  2. Incretins, glucagon and amino acids

    Time frame: 0-120 minutes

    The concentration of incretins and glucagon

  3. 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.

  4. Food Intake

    Time frame: 0 min, 120 minutes

    Energy intake with an ad libitum meat at 120 minutes

  5. 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).

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Mount Saint Vincent University

Other

Collaborators

  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 1, 2022
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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