Glycemic Response to Feeding in Healthy ParticipantsNCT06874400
Comparison of Dairy and Plant-based Alternatives in Adolescents and Older Adults
A study testing Dairy and Plant-based alternative in people with Glycemic Response to Feeding in Healthy Participants and Postprandial Amino Acid Concentrations, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of the Dairy vs Plant study is to compare the effects of dairy and plant-based alternative products on blood sugar regulation and nutrient quality in adolescents and older adults. We are inviting healthy, non-diabetic participants aged 14-18 and 60-75, both males and females to participate. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response to Feeding in Healthy Participants, Postprandial Amino Acid Concentrations, Appetite Regulation
- What is being tested?
- Dairy and Plant-based alternative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2025to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 14-18 years old (adolescents) or 60-75 years old (older adults)
- BMI z-score >+1SD, <+2SD (adolescents) or BMI 25-30 kg/m2 (older adults)
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study.
- Willing to maintain current dietary supplement use throughout the study. On study visit days, subject agrees not to take any supplements until dismissal from the Nutrition Intervention Center.
- Willing to abstain from alcohol consumption for 24hrs prior to all study visits.
- Willing to avoid vigorous physical activity for 24hrs prior to all study visits.
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- Willing to refrain from cannabis use throughout the entire duration of the study.
- Willing to refrain from protein supplement use (e.g. protein powder) throughout the entire duration of the study.
- Understands the study procedures, provides informed consent to participate in the study, and authorizes release of relevant protected health information to the study investigator.
Who cannot join
- Smoking
- Thyroid problems
- Lactose intolerance and/or allergies, intolerances, or sensitivities to study treatments
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
- Presence of gastrointestinal disorder or surgeries within the past year.
- Inability to comply with the experimental procedures and follow our safety guidelines
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- Regular breakfast skipping (>3 days a week)
- On a special diet (e.g. ketogenic, Atkins, high protein) or restrained eaters as identified by a score of >20 on the Eating Attitudes Questionnaire
- Difficulties with eating or swallowing
- Fasting blood glucose >5.6mmol/L measured at screening
- Uncontrolled hypertension (systolic blood pressure >120mmHg, diastolic blood pressure >80mmHg) as defined by the average blood pressure measured at screening
- Weight gain or loss of >10lbs in previous three months
- Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect outcome of the study as per investigator's judgement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Nutrition Intervention Center
Toronto, Ontario, M5S 3H2
Amira Amr, PhD, 416-946-3802, amira.amr@utoronto.ca
Corrina Zhou, MSc, 416-946-3802, corrina.zhou@mail.utoronto.ca
About this study
The purpose of the Dairy vs Plant study is to compare the effects of dairy and plant-based alternative products on blood sugar regulation and nutrient quality in adolescents and older adults. We are inviting healthy, non-diabetic participants aged 14-18 and 60-75, both males and females to participate. The study will take place in the Nutrition Intervention Center located at the Department of Nutritional Sciences, University of Toronto St. George campus. Participants will be asked to come to the Nutrition Intervention Center on 3 separate occasions: once for an in-person screening lasting approximately 30min and 2 times for study visits lasting approximately 2.5 hrs each. The entire study will take a minimum of 2 weeks to complete. You will be asked to fast for 12hrs (overnight) prior to each study visit. You will also be instructed to maintain the same dietary and sleep patterns, refrain from exercise and alcohol consumption the days before the study visits. During these study visits, you will be asked to consume either a dairy or a plant-based alternative product, as well as a pizza meal. You will periodically fill out questionnaires rating your feelings and perceptions and provide blood samples through finger pricks and intravenously through forearm to measure blood sugar, insulin, hormones, and amino acids. You will be compensated for your time and travel expenses.
- Conditions
- Glycemic Response to Feeding in Healthy Participants, Postprandial Amino Acid Concentrations, Appetite Regulation
- Being tested
- Dairy, Plant-based alternative
- Keywords
- Nutrition, dairy, plant-based foods, glycemic response, appetite, protein, food, adolescents, older adults, overweight
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DairyOther
Also called Milk, yogurt, cheese, whey
The dairy products that participants will be required to consume include: 1) Trial 1: 2% cow's milk; 2) Trial 2: dairy yogurt; 3) Trial 3: 2% cottage cheese; 4) Trial 4: 2% cow's milk; and 5) Trial 5: isolated whey protein beverage. Participants will only be enrolled in 1 of the 5 trials; as such, they will only consume the 1 dairy product in that trial.
Plant-based alternativeOther
Also called soy beverage, plant-based yogurt, simulated milk, soy
The plant-based products that participants will be required to consume include: 1) Trial 1: soy beverage; 2) Trial 2: plant-based yogurt; 3) Trial 3: tofu; 4) Trial 4: 2% simulated milk; and 5) Trial 5: isolated soy protein beverage. Participants will only be enrolled in 1 of the 5 trials; as such, they will only consume the 1 plant-based alternative product in that trial.
| Study group | Role | What they receive |
|---|---|---|
| Dairy | Experimental | Participants will consume 2 servings of a commerically available dairy product. Receives: Other: Dairy |
| Plant-based alternative | Experimental | Participants will consume 2 servings of a commercially available plant-based alternative product. Receives: Other: Plant-based alternative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Blood glucose will be measured via finger-prick using a glucose meter at 0, 20, 35, 50, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Secondary outcomes (10)
Insulin
Insulin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Glucagon-like Peptide-1 (GLP-1)
GLP-1 will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Glucagon-like Peptide-2 (GLP-2)
GLP-2 will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Gastric Inhibitory Polypeptide (GIP)
GIP will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Leptin
Leptin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Peptide YY (PYY)
PYY will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Cholecystokinin (CCK)
CCK will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Ghrelin
Ghrelin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Adiponectin
Adiponectin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Amino Acids
Amino acid concentrations will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
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 Glycemic Response to Feeding in Healthy ParticipantsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
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
- NCT06874400
- Sponsor's protocol ID
- 47896
- Other IDs
- 72072239
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared, as all data will be de-identified and pooled during the analysis. Only researchers directly involved in the study will have access to the data.
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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dairy and Plant-based Alternatives in Adolescents and Older Adults
- ClinicalTrials.gov ID
- NCT06874400
- Acronym / sponsor ID
- 47896
- Conditions
- Glycemic Response to Feeding in Healthy Participants, Postprandial Amino Acid Concentrations, Appetite Regulation
- Keywords
- Nutrition, dairy, plant-based foods, glycemic response, appetite, protein, food, adolescents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 13 Mar 2025 (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 the Dairy vs Plant study is to compare the effects of dairy and plant-based alternative products on blood sugar regulation and nutrient quality in adolescents and older adults. We are inviting healthy, non-diabetic participants aged 14-18 and 60-75, both males and females to participate. The study will take place in the Nutrition Intervention Center located at the Department of Nutritional Sciences, University of Toronto St. George campus. Participants will be asked to come to the Nutrition Intervention Center on 3 separate occasions: once for an in-person screening lasting approximately 30min and 2 times for study visits lasting approximately 2.5 hrs each. The entire study will take a minimum of 2 weeks to complete. You will be asked to fast for 12hrs (overnight) prior to each study visit. You will also be instructed to maintain the same dietary and sleep patterns, refrain from exercise and alcohol consumption the days before the study visits. During these study visits, you will be asked to consume either a dairy or a plant-based alternative product, as well as a pizza meal. You will periodically fill out questionnaires rating your feelings and perceptions and provide blood samples through finger pricks and intravenously through forearm to measure blood sugar, insulin, hormones, and amino acids. You will be compensated for your time and travel expenses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy | Experimental | Other: DairyParticipants will consume 2 servings of a commerically available dairy product. |
| Plant-based alternative | Experimental | Other: Plant-based alternativeParticipants will consume 2 servings of a commercially available plant-based alternative product. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age 14-18 years old (adolescents) or 60-75 years old (older adults)
- BMI z-score >+1SD, <+2SD (adolescents) or BMI 25-30 kg/m2 (older adults)
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study.
- Willing to maintain current dietary supplement use throughout the study. On study visit days, subject agrees not to take any supplements until dismissal from the Nutrition Intervention Center.
- Willing to abstain from alcohol consumption for 24hrs prior to all study visits.
Key exclusion criteria (13 listed)
- Smoking
- Thyroid problems
- Lactose intolerance and/or allergies, intolerances, or sensitivities to study treatments
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
- Presence of gastrointestinal disorder or surgeries within the past year.
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 |
|---|---|---|
| DairyAlso: Milk, yogurt, cheese, wheyThe dairy products that participants will be required to consume include: 1) Trial 1: 2% cow's milk; 2) Trial 2: dairy yogurt; 3) Trial 3: 2% cottage cheese; 4) Trial 4: 2% cow's milk; and 5) Trial 5: isolated whey protein beverage. Participants will only be enrolled in 1 of the 5 trials; as such, they will only consume the 1 dairy product in that trial. | Other | Dairy |
| Plant-based alternativeAlso: soy beverage, plant-based yogurt, simulated milk, soyThe plant-based products that participants will be required to consume include: 1) Trial 1: soy beverage; 2) Trial 2: plant-based yogurt; 3) Trial 3: tofu; 4) Trial 4: 2% simulated milk; and 5) Trial 5: isolated soy protein beverage. Participants will only be enrolled in 1 of the 5 trials; as such, they will only consume the 1 plant-based alternative product in that trial. | Other | Plant-based alternative |
Primary outcome
Blood glucose
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Blood glucose will be measured via finger-prick using a glucose meter at 0, 20, 35, 50, 65, 95, 125, and 145 minutes after treatment consumption.
10 secondary outcomes
Insulin
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Glucagon-like Peptide-1 (GLP-1)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Glucagon-like Peptide-2 (GLP-2)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Gastric Inhibitory Polypeptide (GIP)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Leptin
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Peptide YY (PYY)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Cholecystokinin (CCK)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Ghrelin
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Adiponectin
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Amino Acids
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: 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.
- Individual participant dataSharing planned: No. IPD will not be shared, as all data will be de-identified and pooled during the analysis. Only researchers directly involved in the study will have access to the data.
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.
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 alternative in people with Glycemic Response to Feeding in Healthy Participants and Postprandial Amino Acid Concentrations, 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corrina Zhou, MSc (416-946-3802, corrina.zhou@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.). 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 NCT06874400, 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 Mar 2025.