NCT04854603

Brief Summary

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.

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 Sep 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

First Submitted

Initial submission to the registry

April 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

April 10, 2021

Last Update Submit

March 14, 2023

Conditions

Blood Glucose, HighMetabolic DiseaseOverweight and Obesity

Keywords

Sugar intakeSweetenersDiabetesObesitySweetened food productsChocolate milk

Outcome Measures

Primary Outcomes (2)

  • Blood glucose

    The concentration of blood glucose

    0-120 minutes

  • Insulin

    The concentration of blood glucose

    0-120 minutes

Secondary Outcomes (5)

  • Satiety

    0-120 minutes

  • Food intake

    120 minutes

  • Thirst

    0-120 minutes

  • Physical comfort

    0-120 minutes

  • Food pleasantness

    at 0 and 120 minutes

Study Arms (5)

Chocolate milk with a regular added sugar content

EXPERIMENTAL

Dairy product with a regular sugar content

Other: Food

Chocolate milk with a reduced added sugar content

EXPERIMENTAL

Dairy product with a reduced sugar content

Other: Food

Yogurt with a regular added sugar content

EXPERIMENTAL

Dairy product with a regular sugar content

Other: Food

Yogurt with a reduced added sugar content

EXPERIMENTAL

Dairy product with a reduced sugar content

Other: Food

Energy-free control

EXPERIMENTAL

Potable water

Other: Food

Interventions

FoodOTHER

Dairy products with regular and reduced sugar content and water control.

Chocolate milk with a reduced added sugar contentChocolate milk with a regular added sugar contentEnergy-free controlYogurt with a reduced added sugar contentYogurt with a regular added sugar content

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 Mellitus

Interventions

Food

Condition Hierarchy (Ancestors)

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

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Treatments will be blinded. The Investigator will be blinded.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 22, 2021

Study Start

September 2, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)