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

NCT ID: NCT06874400

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2028-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Glycemic Response to Feeding in Healthy Participants Postprandial Amino Acid Concentrations Appetite Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dairy

Participants will consume 2 servings of a commerically available dairy product.

Group Type EXPERIMENTAL

Dairy

Intervention Type 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.

Plant-based alternative

Participants will consume 2 servings of a commercially available plant-based alternative product.

Group Type EXPERIMENTAL

Plant-based alternative

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Milk yogurt cheese whey soy beverage plant-based yogurt simulated milk soy tofu

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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G. Harvey Anderson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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G. Harvey Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Nutrition Intervention Center

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Corrina Zhou, MSc

Role: CONTACT

416-946-3802

Amira Amr, PhD

Role: CONTACT

416-946-3802

Facility Contacts

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Amira Amr, PhD

Role: primary

416-946-3802

Corrina Zhou, MSc

Role: backup

416-946-3802

References

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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.

Reference Type BACKGROUND
PMID: 39146559 (View on PubMed)

Other Identifiers

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72072239

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

47896

Identifier Type: -

Identifier Source: org_study_id

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