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.

Study Overview

• Status: Recruiting
• Conditions: Appetite Regulation; Glycemic Response to Feeding in Healthy Participants; Postprandial Amino Acid Concentrations
• Intervention / Treatment: Other: Dairy; Other: Plant-based alternative

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corrina Zhou, MSc; Phone Number: 416-946-3802; Email: corrina.zhou@mail.utoronto.ca
• Study Contact Backup: Name: Amira Amr, PhD; Phone Number: 416-946-3802; Email: amira.amr@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 3H2
      • Recruiting
      • Nutrition Intervention Center
      • Contact: Corrina Zhou, MSc; Phone Number: 416-946-3802; Email: corrina.zhou@mail.utoronto.ca
      • Contact: Amira Amr, PhD; Phone Number: 416-946-3802; Email: amira.amr@utoronto.ca
      • Contact: Alaa Awad, BSc
      • Contact: Courtney Leung, BSc

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin	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)	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)	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)	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	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)	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)	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Appetite	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

• Sponsor: University of Toronto
• Investigators: Principal Investigator: G. Harvey Anderson, PhD, University of Toronto

Publications and helpful links

General Publications

• Da Silva N, Anderson GH, Amr AM, 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 cross-over study. Appl Physiol Nutr Metab. 2024 Aug 15. doi: 10.1139/apnm-2024-0158. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: older adults; overweight; appetite; Nutrition; adolescents; food; protein; dairy; glycemic response; plant-based foods
• Other Study ID 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