Effect of Pre-meal Serving of Dairy and Dairy Alternatives on Post-meal Satiety and Glycaemia in Healthy Young Adults
Primary Purpose
Obesity, Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dairy-based greek yogurt
Dairy-based cheddar cheese
Plant-based yogurt
Plant-based cheese
Sponsored by

About this trial
This is an interventional prevention trial for Obesity focused on measuring Dairy, Yogurt, Cheese, Postprandial glycaemia, Satiety, Plant based dairy alternative
Eligibility Criteria
Inclusion Criteria:
- BMI of 18.5-24.9 kg/m^2
Exclusion Criteria:
- smoke
- skip breakfast
- lactose intolerant
- allergic to study foods
- dislike study foods
- are not comfortable with finger pricking
- take prescription medication less than a year
- undergoing hormonal treatments for less than 1 year
- trying to gain or lose weight
- have diabetes or cardiovascular disease
- restrained eaters (identified by a score of ≥ 11 using the Eating Habits Questionnaire)
Sites / Locations
- University of Toronto
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Dairy-based Greek yogurt
Dairy-based cheddar cheese
Plant-based Greek yogurt
Plant-based cheese
Arm Description
Plain dairy-based Greek yogurt
Mild dairy-based cheddar cheese
Plain plant-based Greek yogurt
Medium cheddar plant-based cheese
Outcomes
Primary Outcome Measures
Change in blood glucose levels
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
Secondary Outcome Measures
Full Information
NCT ID
NCT04600128
First Posted
October 21, 2020
Last Updated
October 12, 2022
Sponsor
University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04600128
Brief Title
Effect of Pre-meal Serving of Dairy and Dairy Alternatives on Post-meal Satiety and Glycaemia in Healthy Young Adults
Official Title
The Effect of Pre-meal Serving of Dairy and Dairy Alternatives on Post-meal Satiety, Food Intake, and Glycaemia in Healthy Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (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
Regular consumption of dairy products is found to negatively associated with metabolic diseases and improve body composition in long term studies and has positive effect on acute glycemia control and satiety. However, new Canada's Food Guide released in 2019 promotes a shift from traditional dairy products to plant-based dairy alternatives. The present study examines the effect of traditional dairy products in comparison with plant-based alternatives on glycemic response and satiety.
Detailed Description
In the past forty years, the prevalence of obesity in adults has doubled, and nearly two thirds of Canadian adults are currently overweight or obese (Kenneth and Eggleton,2016). The incidence of diabetes, heart disease, stroke and certain cancers has also increased correspondingly (Xavier P. 2010). Obesity not only leads to other chronic diseases but also decreases life expectancy and puts a strain on the health care system (Tremmel 2017). Therefore, it is important to find strategies to minimize obesity and type-2 diabetes. Postprandial glycemia (PPG) has been identified to be one of the implications of risk factor of metabolic diseases such as obesity (Black 2012). To better help identify foods that increase satiety and decrease PPG, Health Canada released a draft guidance document to validate health food claims related to "reduction of post-prandial glycaemic response" (Health Canada 2013).
Regular consumption of dairy products correlates with improved body composition and lower incidences of obesity and type 2 diabetes in both observational and long-term clinical studies (Hirahatake et al. 2014; Lee et al. 2018; Murphy et al. 2013; Soedamah-Muthu and de Goede 2018). Within typical dietary patterns, high-fat dairy consumption is inversely associated with the risk of obesity or overweight (Kratz et al. 2013; Rautiainen et al. 2016). Frequent cheese consumption was associated with lower BMI in a 10 year follow-up study (Guo et al. 2018). The hypothesis that these associations between dairy and obesity and chronic metabolic diseases can be attributed to lasting metabolic effects of dairy when consumed with high glycemic carbohydrate or as a between meal snack is supported by short term studies. A recent meta-analysis of clinical trials concluded that, dairy products when consumed alone result in significant decreases in appetite and later energy intake (Onvani et al. 2017). Other recent studies have shown that milk consumed with a high glyemic breakfast cereal significantly reduced PPG as well as appetite in both young (Kung et al. 2018; Law et al. 2017a) and older adults (Law et al. 2017b). Among dairy products, semi solid and solid dairy products such as cheese and yogurt consumed with carbohydrates increased satiety and lowered PPG more than milk or soy beverages (Law et al. 2017b). PPG and appetite were significantly reduced following single serving amounts, of skim-milk, full fat milk, yogurt and cheese when consumed alone (Vien et al. 2019). Appetite measured over three hours was reduced after dairy consumption compared to a water control, particularly skim milk reducing appetite more than full fat milk, yogurt or cheese. Over 120 minutes, PPG was the lowest after cheese (Vien et al. 2019).
This data suggests that dairy consumed immediately before a meal will affect satiety and glycemic responses to a later meal, but the response will depend on the type of dairy product consumed. The updated Canada's Food Guide promotes the consumption of plant-based protein and a shift away from consuming dairy products as plant-based products may provide more fibre and less saturated fat (Canada Food Guide 2019). As a result, many plant based dairy substitutes have appeared in the marketplace. However, these new products, in addition to being of low protein quality, my lack the physiological functionality of dairy in metabolic regulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes Mellitus
Keywords
Dairy, Yogurt, Cheese, Postprandial glycaemia, Satiety, Plant based dairy alternative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dairy-based Greek yogurt
Arm Type
Active Comparator
Arm Description
Plain dairy-based Greek yogurt
Arm Title
Dairy-based cheddar cheese
Arm Type
Active Comparator
Arm Description
Mild dairy-based cheddar cheese
Arm Title
Plant-based Greek yogurt
Arm Type
Active Comparator
Arm Description
Plain plant-based Greek yogurt
Arm Title
Plant-based cheese
Arm Type
Active Comparator
Arm Description
Medium cheddar plant-based cheese
Intervention Type
Other
Intervention Name(s)
Dairy-based greek yogurt
Intervention Description
Plain Greek yogurt (2% M.F; Danone, Boucherville, Quebec, Canada)
Intervention Type
Other
Intervention Name(s)
Dairy-based cheddar cheese
Intervention Description
Mild cheddar cheese (31% M.F. ; Armstrong, Saputo Dairy Products, Saint-Laurent, Quebec, Canada)
Intervention Type
Other
Intervention Name(s)
Plant-based yogurt
Intervention Description
Plain Greek yogurt alternative (Daiya, Rupert Street, Vancouver, Canada)
Intervention Type
Other
Intervention Name(s)
Plant-based cheese
Intervention Description
Medium cheddar style block (Daiya, Rupert Street, Vancouver, Canada)
Primary Outcome Measure Information:
Title
Change in blood glucose levels
Description
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
Time Frame
Starting at the beginning of each session (0 minutes before consumption of treatment) and every 15-30 minutes up to 160 minutes (time of completion of each session)
Other Pre-specified Outcome Measures:
Title
Subjective appetite
Description
Measured using Visual Analog Scales (VAS). Subjective appetite is determine by desire to eat, hunger, fullness, and prospective consumption. The scale is 0 to 100 where zero indicates low desire to eat, hunger, prospective consumption and lesser fullness. One hundred indicates high desire to eat, hunger, prospective consumption, and greater fullness,
Time Frame
up to 160 minutes (time of completion of each session)
Title
Insulin
Description
Blood insulin (μU/mL) is measured using finger prick capillary blood samples
Time Frame
up to 160 minutes (time of completion of each session)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI of 18.5-24.9 kg/m^2
Exclusion Criteria:
smoke
skip breakfast
lactose intolerant
allergic to study foods
dislike study foods
are not comfortable with finger pricking
take prescription medication less than a year
undergoing hormonal treatments for less than 1 year
trying to gain or lose weight
have diabetes or cardiovascular disease
restrained eaters (identified by a score of ≥ 11 using the Eating Habits Questionnaire)
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
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3H2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of Pre-meal Serving of Dairy and Dairy Alternatives on Post-meal Satiety and Glycaemia in Healthy Young Adults
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