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Dairy Products With Reduced Sugar and Blood Glucose

Primary Purpose

Blood Glucose, High, Metabolic Disease, Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Food

About this trial

This is an interventional prevention trial for Blood Glucose, High focused on measuring Sugar intake, Sweeteners, Diabetes, Obesity, Sweetened food products, Chocolate milk

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mount Saint Vincent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Chocolate milk with a regular added sugar content

Chocolate milk with a reduced added sugar content

Yogurt with a regular added sugar content

Yogurt with a reduced added sugar content

Energy-free control

Arm Description

Dairy product with a regular sugar content

Dairy product with a reduced sugar content

Dairy product with a regular sugar content

Dairy product with a reduced sugar content

Potable water

Outcomes

Primary Outcome Measures

Blood glucose

The concentration of blood glucose

Insulin

The concentration of blood glucose

Secondary Outcome Measures

Satiety

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

Energy intake with an ad libitum meat at 120 minutes

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).

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.

Food pleasantness

The perception of pleasantness of the treatments (0 min) and a test meal (at 120 min) will be measured with 100mm visual analogue scale.

Full Information

NCT ID

NCT04854603

First Posted

April 10, 2021

Last Updated

March 14, 2023

Sponsor

Mount Saint Vincent University

1. Study Identification

Unique Protocol Identification Number

NCT04854603

Brief Title

Dairy Products With Reduced Sugar and Blood Glucose

Official Title

The Effect of Dairy Products With Reduced Added Sugar Content on Blood Glucose, Satiety and Food Intake

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

September 2, 2021 (Actual)

Primary Completion Date

August 31, 2022 (Actual)

Study Completion Date

August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mount Saint Vincent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Glucose, High, Metabolic Disease, Overweight and Obesity

Keywords

Sugar intake, Sweeteners, Diabetes, Obesity, Sweetened food products, Chocolate milk

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Masking Description

Treatments will be blinded. The Investigator will be blinded.

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chocolate milk with a regular added sugar content

Arm Type

Experimental

Arm Description

Dairy product with a regular sugar content

Arm Title

Chocolate milk with a reduced added sugar content

Arm Type

Experimental

Arm Description

Dairy product with a reduced sugar content

Arm Title

Yogurt with a regular added sugar content

Arm Type

Experimental

Arm Description

Dairy product with a regular sugar content

Arm Title

Yogurt with a reduced added sugar content

Arm Type

Experimental

Arm Description

Dairy product with a reduced sugar content

Arm Title

Energy-free control

Arm Type

Experimental

Arm Description

Potable water

Intervention Type

Other

Intervention Name(s)

Food

Intervention Description

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

Primary Outcome Measure Information:

Title

Blood glucose

Description

The concentration of blood glucose

Time Frame

0-120 minutes

Title

Insulin

Description

The concentration of blood glucose

Time Frame

0-120 minutes

Secondary Outcome Measure Information:

Title

Satiety

Description

The components of average subjective appetite including desire to eat, hunger, fullness, and a prospective food consumption measured with 100mm visual analogue scales.

Time Frame

0-120 minutes

Title

Food intake

Description

Energy intake with an ad libitum meat at 120 minutes

Time Frame

120 minutes

Title

Thirst

Description

Time Frame

0-120 minutes

Title

Physical comfort

Description

Time Frame

0-120 minutes

Title

Food pleasantness

Description

The perception of pleasantness of the treatments (0 min) and a test meal (at 120 min) will be measured with 100mm visual analogue scale.

Time Frame

at 0 and 120 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bohdan Luhovyy, PhD

Organizational Affiliation

Mount Saint Vincent University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Saint Vincent University

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3M 2J6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Dairy Products With Reduced Sugar and Blood Glucose

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