- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600128
Effect of Pre-meal Serving of Dairy and Dairy Alternatives on Post-meal Satiety and Glycaemia in Healthy Young Adults
The Effect of Pre-meal Serving of Dairy and Dairy Alternatives on Post-meal Satiety, Food Intake, and Glycaemia in Healthy Young Adults
Study Overview
Status
Conditions
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 To better help identify foods that increase satiety and decrease PPG, Health Canada released a draft guidance document to validate health food claims related to "reduction of post-prandial glycaemic response" (Health Canada 2013).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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 3H2
- University of Toronto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dairy-based Greek yogurt
Plain dairy-based Greek yogurt
|
Plain Greek yogurt (2% M.F; Danone, Boucherville, Quebec, Canada)
|
Active Comparator: Dairy-based cheddar cheese
Mild dairy-based cheddar cheese
|
Mild cheddar cheese (31% M.F. ; Armstrong, Saputo Dairy Products, Saint-Laurent, Quebec, Canada)
|
Active Comparator: Plant-based Greek yogurt
Plain plant-based Greek yogurt
|
Plain Greek yogurt alternative (Daiya, Rupert Street, Vancouver, Canada)
|
Active Comparator: Plant-based cheese
Medium cheddar plant-based cheese
|
Medium cheddar style block (Daiya, Rupert Street, Vancouver, Canada)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood glucose levels
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)
|
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective appetite
Time Frame: up to 160 minutes (time of completion of each session)
|
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,
|
up to 160 minutes (time of completion of each session)
|
Insulin
Time Frame: up to 160 minutes (time of completion of each session)
|
Blood insulin (μU/mL) is measured using finger prick capillary blood samples
|
up to 160 minutes (time of completion of each session)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DFC_31323_PlantProtein
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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