Dairy Products With Reduced Sugar and Blood Glucose

Sponsor

Mount Saint Vincent University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04854603

Collaborator

(none)

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

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:

Double (Participant, Investigator)

Masking Description:

Treatments will be blinded. The Investigator will be blinded.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 2, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chocolate milk with a regular added sugar content Dairy product with a regular sugar content	Other: Food Dairy products with regular and reduced sugar content and water control.
Experimental: Chocolate milk with a reduced added sugar content Dairy product with a reduced sugar content	Other: Food Dairy products with regular and reduced sugar content and water control.
Experimental: Yogurt with a regular added sugar content Dairy product with a regular sugar content	Other: Food Dairy products with regular and reduced sugar content and water control.
Experimental: Yogurt with a reduced added sugar content Dairy product with a reduced sugar content	Other: Food Dairy products with regular and reduced sugar content and water control.
Experimental: Energy-free control Potable water	Other: Food Dairy products with regular and reduced sugar content and water control.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 [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.