Clinical trial NCT06874400: Comparison of Dairy and Plant-based Alternatives in Adolescents and Older Adults
Official title: Comparison of Dairy and Plant-based Alternatives in Adolescents and Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Secondary outcomes:
measure: Insulin
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Glucagon-like Peptide-1 (GLP-1)
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Glucagon-like Peptide-2 (GLP-2)
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Gastric Inhibitory Polypeptide (GIP)
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Leptin
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Peptide YY (PYY)
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Cholecystokinin (CCK)
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Ghrelin
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Adiponectin
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
measure: Amino Acids
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Other outcomes:
measure: Appetite
timeFrame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Locations:
city: Toronto
country: Canada
facility: Nutrition Intervention Center
state: Ontario
Study officials:
affiliation: University of Toronto
name: G. Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.