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

NCT06874400 | Recruiting

• 2 other identifiers: 4789672072239
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Nutrition; dairy; plant-based foods; glycemic response; appetite; protein; food; adolescents; older adults; overweight

Outcome Measures

Primary Outcomes (1)

• 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.

  Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

Secondary Outcomes (10)

• Insulin

  Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

• Glucagon-like Peptide-1 (GLP-1)

  Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

• Glucagon-like Peptide-2 (GLP-2)

  Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

• Gastric Inhibitory Polypeptide (GIP)

  Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

• Leptin

  Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

Other Outcomes (1)

• Appetite

  Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

Study Arms (2)

Dairy

EXPERIMENTAL

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

Other: Dairy

Plant-based alternative

EXPERIMENTAL

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

Other: Plant-based alternative

Interventions

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.

Also known as: Milk, yogurt, cheese, whey

Dairy

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.

Also known as: soy beverage, plant-based yogurt, simulated milk, soy, tofu

Plant-based alternative

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Nutrition Intervention Center

Toronto, Ontario, M5S 3H2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 39146559 BACKGROUND

MeSH Terms

Conditions

Overweight

Interventions

Milk; Yogurt; Cheese; Whey; Meat Substitutes; Soy Milk; Soy Foods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Cultured Milk Products; Fermented Foods; Milk Substitutes; Vegetable Products; Vegetables

Study Officials

• G. Harvey Anderson, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corrina Zhou, MSc

CONTACT

416-946-3802; corrina.zhou@mail.utoronto.ca

Amira Amr, PhD

CONTACT

416-946-3802; amira.amr@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 13, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)