NCT05400694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

May 26, 2022

Last Update Submit

October 17, 2023

Conditions

Blood Glucose, HighMetabolic DiseaseOverweight and Obesity

Keywords

Sugar intakeSweetenersMilk ProteinsDiabetesObesitySweetened food productsChocolate milkBlood glucoseInsulinSatietyFood IntakeCaseinWhey protein

Outcome Measures

Primary Outcomes (2)

  • Blood glucose

    The concentration of blood glucose

    0-120 minutes

  • Insulin

    The concentration of insulin

    0-120 minutes

Secondary Outcomes (7)

  • C-peptide

    0-120 minutes

  • Incretins, glucagon and amino acids

    0-120 minutes

  • Satiety

    0-120 minutes

  • Food Intake

    0 min, 120 minutes

  • Thirst

    0-120 minutes

  • +2 more secondary outcomes

Study Arms (5)

Chocolate milk

EXPERIMENTAL

Chocolate milk with reduced added sugar

Other: Food

Chocolate milk with whey protein

EXPERIMENTAL

Chocolate milk with reduced added sugar and added whey protein

Other: Food

Chocolate milk with casein

EXPERIMENTAL

Chocolate milk with reduced added sugar and added casein

Other: Food

Chocolate milk with alpha-lactalbumin

EXPERIMENTAL

Chocolate milk with reduced added sugar and added alpha-lactalbumin

Other: Food

Chocolate milk with glycomacropeptide

EXPERIMENTAL

Chocolate milk with reduced added sugar and added glycomacropeptide

Other: Food

Interventions

FoodOTHER

Dairy products with reduced sugar content

Chocolate milkChocolate milk with alpha-lactalbuminChocolate milk with caseinChocolate milk with glycomacropeptideChocolate milk with whey protein

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • y males and females, non-smokers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Location

MeSH Terms

Conditions

Metabolic DiseasesOverweightObesityDiabetes MellitusInsulin Resistance

Interventions

Food

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bohdan Luhovyy, PhD

    Mount Saint Vincent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Treatments are blinded.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

October 1, 2021

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)