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NCT Number: NCT06874400

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

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.

Recruiting

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Key information

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dairy

Other

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: Milk, yogurt, cheese, whey

Plant-based alternative

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Amr, PhD

CONTACT

[email protected]

416-946-3802

Corrina Zhou, MSc

CONTACT

[email protected]

416-946-3802

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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