ObesityNCT05919667
Dairy and Non-Dairy Alternatives Comparative on Metabolic Outcomes
A study testing Dairy and plant-based dairy beverages and solids in people with Obesity and Diabetes Mellitus, Type 2, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Dairy and plant-based dairy beverages and solids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 28 Feb 2022to 31 Mar 2023
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Nutritional Sciences, C. David Naylor Building
Toronto, Ontario, M5S 3H2
About this study
Official title: The Effects of Dairy and Non-Dairy Alternatives on Glycemic and Appetite Regulation in Healthy Young Adults
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.
Read the 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.
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Dairy and plant-based dairy beverages and solids
- Keywords
- Dairy, Post-prandial glycemia, Appetite, Satiety, Gut Hormone Responses
- 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 and plant-based dairy beverages and solidsDietary supplement
Crossover design: participants received all treatment arms in a randomized order
| Study group | Role | What they receive |
|---|---|---|
| Dairy-based Product 1 | Experimental | 2% Cow's milk (Neilson, St-Laurent, Quebec) Receives: Dietary Supplement: Dairy and plant-based dairy beverages and solids |
| Dairy-based Product 2 | Experimental | Regular fat cheddar cheese (Armstrong, St-Laurent, Québec) Receives: Dietary Supplement: Dairy and plant-based dairy beverages and solids |
| Plant-based Product 3: | Experimental | Vanilla Soy Beverage (Silk, Broomfield, Colorado) Receives: Dietary Supplement: Dairy and plant-based dairy beverages and solids |
| Plant-based Product 4 | Experimental | Vanilla Almond Beverage (Earth's Own, Vancouver, British Columbia) Receives: Dietary Supplement: Dairy and plant-based dairy beverages and solids |
| Plant-based Product 5 | Experimental | Plant-based Cheddar-Style Block (President' Choice, Brampton, Ontario) Receives: Dietary Supplement: Dairy and plant-based dairy beverages and solids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose level
Venous blood collection via catheter
Measured: 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 outcomes (3)
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?
Measured: Measured every 15-30 minutes up to 160 minutes]. A total of 9 times.
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
Measured: 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.
Change in plasma amino acid concentrations
Venous blood collection via catheter
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start28 Feb 2022
- Primary completion28 Feb 2022
- Study completion31 Mar 2023
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
- Basic science
- 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
- NCT05919667
- Sponsor's protocol ID
- MYC_AcuteDairy_2022
- Status last verified
- Jun 2023
- First submitted
- 28 Feb 2022
- Last updated
- 26 Jun 2023
- 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 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dairy and Non-Dairy Alternatives on Glycemic and Appetite Regulation in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT05919667
- Acronym / sponsor ID
- MYC_AcuteDairy_2022
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Keywords
- Dairy, Post-prandial glycemia, Appetite, Satiety, Gut Hormone Responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 Jun 2023 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dairy-based Product 1 | Experimental | Dietary Supplement: Dairy and plant-based dairy beverages and solids2% Cow's milk (Neilson, St-Laurent, Quebec) |
| Dairy-based Product 2 | Experimental | Dietary Supplement: Dairy and plant-based dairy beverages and solidsRegular fat cheddar cheese (Armstrong, St-Laurent, Québec) |
| Plant-based Product 3: | Experimental | Dietary Supplement: Dairy and plant-based dairy beverages and solidsVanilla Soy Beverage (Silk, Broomfield, Colorado) |
| Plant-based Product 4 | Experimental | Dietary Supplement: Dairy and plant-based dairy beverages and solidsVanilla Almond Beverage (Earth's Own, Vancouver, British Columbia) |
| Plant-based Product 5 | Experimental | Dietary Supplement: Dairy and plant-based dairy beverages and solidsPlant-based Cheddar-Style Block (President' Choice, Brampton, Ontario) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
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 and plant-based dairy beverages and solidsCrossover design: participants received all treatment arms in a randomized order | Dietary supplement | Dairy-based Product 1, Dairy-based Product 2, Plant-based Product 3:, Plant-based Product 4, Plant-based Product 5 |
Primary outcome
Change in blood glucose level
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.
Venous blood collection via catheter
3 secondary outcomes
Subjective appetite
Time frame: Measured every 15-30 minutes up to 160 minutes]. A total of 9 times.
Change in plasma metabolic and gut hormones (insulin, c-peptide, glucagon-like 1 receptor, glucagon-like 2 peptide and gastric inhibitory polypeptide)
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.
Change in plasma amino acid concentrations
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.
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 26 Jun 2023.
- 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 and plant-based dairy beverages and solids in people with Obesity and Diabetes Mellitus, Type 2, 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 7 inclusion and 14 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 26 Jun 2023. 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 level (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.). 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 NCT05919667, 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 26 Jun 2023.