Comparison of Dairy and Plant-based Alternatives in Adolescents and Older Adults

March 7, 2025 updated by: G. Harvey Anderson, University of Toronto
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 3H2
        • Recruiting
        • Nutrition Intervention Center
        • Contact:
        • Contact:
        • Contact:
          • Alaa Awad, BSc
        • Contact:
          • Courtney Leung, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dairy
Participants will consume 2 servings of a commerically available dairy product.
Other: Dairy
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.
Other Names:
  • whey
  • Milk
  • yogurt
  • cheese
Experimental: Plant-based alternative
Participants will consume 2 servings of a commercially available plant-based alternative product.
Other: Plant-based alternative
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.
Other Names:
  • soy beverage
  • plant-based yogurt
  • simulated milk
  • soy
  • tofu

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin
Time Frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Insulin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
GLP-1 will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
GLP-2 will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
GIP will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
Leptin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
PYY will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
CCK will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
Ghrelin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
Adiponectin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 95, 125, and 145 minutes after treatment consumption.
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.
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.
Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Appetite
Time Frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Appetite will be assessed through Adaptive Visual Analogue Scales (AVAS) questionnaires completed at 0, 20, 35, 50, 65, 95, 125 and 145 minutes after treatment consumption, and through an ad libitum pizza meal provided at 125 minutes post-treatment consumption, where participants will be instructed to eat until they are comfortably full over 20 minutes.
Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: G. Harvey Anderson, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 47896
  • 72072239 (Other Grant/Funding Number: Dairy Farmers of Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings