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Dairy and Non-Dairy Alternatives Comparative on Metabolic Outcomes

Primary Purpose

Obesity, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dairy and plant-based dairy beverages and solids
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Dairy, Post-prandial glycemia, Appetite, Satiety, Gut Hormone Responses

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: BMI: ≥18.5 kg/m2 and ≤ 24.5 kg/m2' Fasting serum glucose: ≤ 5.5 mmol/L Frequent breakfast consumers Willing to maintain habitual diet, physical activity pattern, dietary supplement routine, and body weight throughout the trial Willing to abstain from alcohol consumption for 24 h prior to all test visits. Willing to avoid vigorous physical activity for 24 h prior to all test visits. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. Exclusion Criteria: Fasting blood glucose > 5.5 mmol/L Smoking tobacco products and marijuana regularly Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease Presence of gastrointestinal disorder or surgeries within the past year Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose, appetite and/or any other outcomes of the study as per investigator's judgment Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months Irregular menstrual cycles (i.e., frequent missed cycles), menopausal or post- menopausal Breakfast skippers Currently trying to lose or gain weight and any weight gain or loss of at least 10 lbs in previous three months Known intolerance, sensitivity or allergy to dairy products (including milk and cheese) Consumption of powders/protein supplements Extreme dietary habits Excessive alcohol intake Restrained Eaters

Sites / Locations

  • Department of Nutritional Sciences, C. David Naylor Building

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dairy-based Product 1

Dairy-based Product 2

Plant-based Product 3:

Plant-based Product 4

Plant-based Product 5

Arm Description

2% Cow's milk (Neilson, St-Laurent, Quebec)

Regular fat cheddar cheese (Armstrong, St-Laurent, Québec)

Vanilla Soy Beverage (Silk, Broomfield, Colorado)

Vanilla Almond Beverage (Earth's Own, Vancouver, British Columbia)

Plant-based Cheddar-Style Block (President' Choice, Brampton, Ontario)

Outcomes

Primary Outcome Measures

Change in blood glucose level
Venous blood collection via catheter

Secondary Outcome Measures

Subjective appetite
Quantifying appetite by using Visual Analogue Scales. Scored 0 to 100 How strong is your desire to eat? How hungry do you feel? How full do you feel? How much food do you think you could eat?
Change in plasma metabolic and gut hormones (insulin, c-peptide, glucagon-like 1 receptor, glucagon-like 2 peptide and gastric inhibitory polypeptide)
Venous blood collection via catheter
Change in plasma amino acid concentrations
Venous blood collection via catheter

Full Information

First Posted
February 28, 2022
Last Updated
June 22, 2023
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05919667
Brief Title
Dairy and Non-Dairy Alternatives Comparative on Metabolic Outcomes
Official Title
The Effects of Dairy and Non-Dairy Alternatives on Glycemic and Appetite Regulation in Healthy Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the acute effects of a single serving of dairy and non-dairy alternatives on post-treatment and post-meal glycemia, appetite, plasma amino acid concentrations, and gastrointestinal hormones levels.
Detailed Description
In the past forty years, the prevalence of obesity in adults has doubled with nearly two thirds of Canadian adults currently overweight or obese. The global epidemic of obesity also makes certain individuals more vulnerable to common co-morbidities of obesity, such as type-2-diabetes. To combat these rising numbers, Health Canada released a new Canadian Food Guide (CFG) in 2019. One particular alteration to the new CFG includes dietary guidelines encouraging for an increased consumption of plant-based foods as protein rich sources, shifting away from the promotion of animal-based food products, such as dairy. However, many of the available plant-based substitutes in the market are highly processed with high amounts of sugar, fat, sodium, and additives compared to animal-based products. While literature has shown for plant-based foods to confer numerous health benefits, these are often plant-based foods that have been unprocessed, except for cooking. As the demand for plant-based products continues to grow annually, it is important to assess and compare various obesity and T2D related metabolic outcomes, such as glycemic regulation and appetite control, to better understand the physiological functionality of these products and what role they may or may not play in mitigating the obesity and T2D global epidemics. There is a growing body of evidence from clinical and meta-analysis trials that show dairy products reduce satiety and provide better glycemic control; highlighting their potential to help reduce risk factors associated with obesity and T2D. However, literature has mainly focused on nutrient profile or isolated protein comparatives between animal and plant-based sources. Instead, this study will be looking at comparing dairy products and their plant-based counterparts with respect to their food matrix as a whole, to understand what responses these products produce in the form consumers are naturally eating them by. This study will focus on assessing the metabolic outcomes related to satiety and glycemic regulation. Satiety is an important physiological function related to food intake, and thus, provides a measure to assess reduced obesity risk. Additionally, postprandial glycemic control is an important physiological function that is not only related to the development of type-2 diabetes but also satiety. A total of 16 participants (8 males and 8 females) will participate in this study at the University of Toronto. The study will include a total of 5 sessions over the span of 5 weeks. Prior to the visit, participants will be fasted for 12 hours, excluding water for up to 1 hour before the study visit. During each session, participants will consume a dairy product or a non-dairy plant-based product while subjective appetite, blood glucose, insulin, C-peptide, and gut hormones (ghrelin, GLP-1, GLP-2, and GIP) are obtained post-treatment at 20 min and post a secondary fixed meal of pasta within 15-30 min intervals over a 2 hour timespan. Plasma amino acid concentrations will also be measured within the same timeline outlined above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus, Type 2
Keywords
Dairy, Post-prandial glycemia, Appetite, Satiety, Gut Hormone Responses

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Randomized, single-blinded
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dairy-based Product 1
Arm Type
Experimental
Arm Description
2% Cow's milk (Neilson, St-Laurent, Quebec)
Arm Title
Dairy-based Product 2
Arm Type
Experimental
Arm Description
Regular fat cheddar cheese (Armstrong, St-Laurent, Québec)
Arm Title
Plant-based Product 3:
Arm Type
Experimental
Arm Description
Vanilla Soy Beverage (Silk, Broomfield, Colorado)
Arm Title
Plant-based Product 4
Arm Type
Experimental
Arm Description
Vanilla Almond Beverage (Earth's Own, Vancouver, British Columbia)
Arm Title
Plant-based Product 5
Arm Type
Experimental
Arm Description
Plant-based Cheddar-Style Block (President' Choice, Brampton, Ontario)
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy and plant-based dairy beverages and solids
Intervention Description
Crossover design: participants received all treatment arms in a randomized order
Primary Outcome Measure Information:
Title
Change in blood glucose level
Description
Venous blood collection via catheter
Time Frame
Starting at the beginning of each sessions (0 min, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 9 times.
Secondary Outcome Measure Information:
Title
Subjective appetite
Description
Quantifying appetite by using Visual Analogue Scales. Scored 0 to 100 How strong is your desire to eat? How hungry do you feel? How full do you feel? How much food do you think you could eat?
Time Frame
Measured every 15-30 minutes up to 160 minutes]. A total of 9 times.
Title
Change in plasma metabolic and gut hormones (insulin, c-peptide, glucagon-like 1 receptor, glucagon-like 2 peptide and gastric inhibitory polypeptide)
Description
Venous blood collection via catheter
Time Frame
Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 7 times.
Title
Change in plasma amino acid concentrations
Description
Venous blood collection via catheter
Time Frame
Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15-30 minutes up to 160 minutes]. A total of 7 times.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI: ≥18.5 kg/m2 and ≤ 24.5 kg/m2' Fasting serum glucose: ≤ 5.5 mmol/L Frequent breakfast consumers Willing to maintain habitual diet, physical activity pattern, dietary supplement routine, and body weight throughout the trial Willing to abstain from alcohol consumption for 24 h prior to all test visits. Willing to avoid vigorous physical activity for 24 h prior to all test visits. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. Exclusion Criteria: Fasting blood glucose > 5.5 mmol/L Smoking tobacco products and marijuana regularly Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease Presence of gastrointestinal disorder or surgeries within the past year Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose, appetite and/or any other outcomes of the study as per investigator's judgment Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months Irregular menstrual cycles (i.e., frequent missed cycles), menopausal or post- menopausal Breakfast skippers Currently trying to lose or gain weight and any weight gain or loss of at least 10 lbs in previous three months Known intolerance, sensitivity or allergy to dairy products (including milk and cheese) Consumption of powders/protein supplements Extreme dietary habits Excessive alcohol intake Restrained Eaters
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Harvey Anderson, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutritional Sciences, C. David Naylor Building
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3H2
Country
Canada

12. IPD Sharing Statement

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Dairy and Non-Dairy Alternatives Comparative on Metabolic Outcomes

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