ObesityNCT04600128
Effect of Pre-meal Serving of Dairy and Dairy Alternatives on Post-meal Satiety and Glycaemia in Healthy Young Adults
A study testing Dairy-based greek yogurt, Dairy-based cheddar cheese and Plant-based yogurt in people with Obesity and Type 2 Diabetes Mellitus, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Dairy-based greek yogurt, Dairy-based cheddar cheese and Plant-based yogurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 18 Nov 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 18.5-24.9 kg/m^2
Who cannot join
- smoke
- skip breakfast
- lactose intolerant
- allergic to study foods
- dislike study foods
- are not comfortable with finger pricking
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Dairy-based greek yogurt, Dairy-based cheddar cheese, Plant-based yogurt, Plant-based cheese
- Keywords
- Dairy, Yogurt, Cheese, Postprandial glycaemia, Satiety, Plant based dairy alternative
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy-based greek yogurtOther
Plain Greek yogurt (2% M.F; Danone, Boucherville, Quebec, Canada)
Dairy-based cheddar cheeseOther
Mild cheddar cheese (31% M.F. ; Armstrong, Saputo Dairy Products, Saint-Laurent, Quebec, Canada)
Plant-based yogurtOther
Plain Greek yogurt alternative (Daiya, Rupert Street, Vancouver, Canada)
Plant-based cheeseOther
Medium cheddar style block (Daiya, Rupert Street, Vancouver, Canada)
| Study group | Role | What they receive |
|---|---|---|
| Dairy-based Greek yogurt | Active comparator | Plain dairy-based Greek yogurt Receives: Other: Dairy-based greek yogurt |
| Dairy-based cheddar cheese | Active comparator | Mild dairy-based cheddar cheese Receives: Other: Dairy-based cheddar cheese |
| Plant-based Greek yogurt | Active comparator | Plain plant-based Greek yogurt Receives: Other: Plant-based yogurt |
| Plant-based cheese | Active comparator | Medium cheddar plant-based cheese Receives: Other: Plant-based cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose levels
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start18 Nov 2019
- Primary completion31 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G. Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600128
- Sponsor's protocol ID
- DFC_31323_PlantProtein
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Da Silva N, Anderson G, Amr A, Vien S, Fabek H. A comparison of the effects of dairy products with their plant-based alternatives on metabolic responses in healthy young Canadian adults: a randomized crossover study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-17. doi: 10.1139/apnm-2024-0158.
PubMed 39146559
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04600128
- Acronym / sponsor ID
- DFC_31323_PlantProtein
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Dairy, Yogurt, Cheese, Postprandial glycaemia, Satiety, Plant based dairy alternative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dairy-based Greek yogurt | Active comparator | Other: Dairy-based greek yogurtPlain dairy-based Greek yogurt |
| Dairy-based cheddar cheese | Active comparator | Other: Dairy-based cheddar cheeseMild dairy-based cheddar cheese |
| Plant-based Greek yogurt | Active comparator | Other: Plant-based yogurtPlain plant-based Greek yogurt |
| Plant-based cheese | Active comparator | Other: Plant-based cheeseMedium cheddar plant-based cheese |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI of 18.5-24.9 kg/m^2
Key exclusion criteria (11 listed)
- smoke
- skip breakfast
- lactose intolerant
- allergic to study foods
- dislike study foods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy-based greek yogurtPlain Greek yogurt (2% M.F; Danone, Boucherville, Quebec, Canada) | Other | Dairy-based Greek yogurt |
| Dairy-based cheddar cheeseMild cheddar cheese (31% M.F. ; Armstrong, Saputo Dairy Products, Saint-Laurent, Quebec, Canada) | Other | Dairy-based cheddar cheese |
| Plant-based yogurtPlain Greek yogurt alternative (Daiya, Rupert Street, Vancouver, Canada) | Other | Plant-based Greek yogurt |
| Plant-based cheeseMedium cheddar style block (Daiya, Rupert Street, Vancouver, Canada) | Other | Plant-based cheese |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 39146559Da Silva N, Anderson G, Amr A, Vien S, Fabek H. A comparison of the effects of dairy products with their plant-based alternatives on metabolic responses in healthy young Canadian adults: a randomized crossover study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-17. doi: 10.1139/apnm-2024-0158.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Harvey Anderson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy-based greek yogurt, Dairy-based cheddar cheese and Plant-based yogurt in people with Obesity and Type 2 Diabetes Mellitus, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.