Dairy ConsumptionNCT06879652
The Effect of Dairy Intake on Body Weight and Composition and Metabolic Health in Adolescents and Seniors
A study testing Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study), Dairy (short-term study) and Counselling to follow Canada's Food Guide (long-term study) in people with Dairy Consumption and Metabolic Health, run by University of Toronto at 2 sites in Canada.
Trial summary
The goal of this study is to examine how regular dairy intake affects body weight, body composition, and metabolic health in overweight and obese adolescents (ages 15-18) and older adults (ages 60-80) over six months. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Dairy Consumption, Metabolic Health, Obesity Prevention
- What is being tested?
- Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study), Dairy (short-term study) and Counselling to follow Canada's Food Guide (long-term study)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 15-18 years old (adolescents) or 60-80 years old (seniors)
- BMI z-score >+1SD, <+2SD (adolescents) or BMI 25-34.9 kg/m2 (seniors)
- Waist circumference > 80 cm for women and > 94 cm for men (seniors)
- FBG 5.6-6.9 mmol/L (prediabetes)
- Willing to follow Canada's Food Guide
- Willing to maintain current dietary supplement use throughout the study.
Show all 18Show fewer
- Willing to abstain from alcohol consumption for 24 hours before all test visits.
- Willing to avoid vigorous physical activity for 24 hours before all test visits.
- Understands the study procedures and is willing to provide informed consent by the parent/guardian and assent by participant to participate in the study and authorization to release relevant protected health information to the study investigator.
- 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.
Who cannot join
- Fasting BG ≥ 7 mmol/L
- Blood pressure systolic ≥ 130mmHg or diastolic ≥ 80mmHg (adolescents) or systolic ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg
- Smoking (tobacco and/or cannabis product use in the last 6 months)
- Thyroid problems
- History of CVDs, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorption syndrome, pancreatitis, gallbladder, or biliary disease.
- Presence of gastrointestinal disorder or surgeries within the past year.
Show all 28Show fewer
- Use of the prescription or non-prescription drugs, herbal or nutritional supplements known to affect the outcome of the study as per the investigator's judgment (including prebiotics and probiotics).
- Known to be pregnant, lactating, or not postmenopausal for at least a year and/or is taking hormonal treatments
- Unwillingness or inability to comply with the experimental procedures
- Known intolerance, sensitivity, or allergy to dairy, gluten, or any other study treatments.
- Consumption of protein powders/supplements
- Extreme dietary habits (e.g., Atkins diet, very high-protein diets, etc.)
- Weight gain or loss of > 5% in the previous three months.
- Excessive alcohol intake (more than 2 drinks per day or 9 per week)
- Restrained eating, identified by a score of ≥11 on the Eating Habits Questionnaire
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Department of Nutritional Sciences
Toronto, Ontario, M5S 1A8
Shekoufeh SS Salamat, Ph.D., 416-946-3802, s.salamat@utoronto.ca
Corrina CZ Zhou, Master's degree, 416-946-3802, corinna.zhou@email.utoronto.ca
- Not yet recruiting
Nutrition Intervention Center
Toronto, M5S 3H2
Shekoufeh Salamat, Ph.D., 647-657-5242, s.salamat@utoronto.ca
Corrina Zhou, MSc, 416-946-3802, corrina.zhou@mail.utoronto.ca
About this study
The goal of this study is to examine how regular dairy intake affects body weight, body composition, and metabolic health in overweight and obese adolescents (ages 15-18) and older adults (ages 60-80) over six months. We are inviting eligible individuals to participate in this study at the Nutrition Intervention Center, Department of Nutritional Sciences, University of Toronto. Participants will be randomly divided into two groups. The intervention (dairy) group will consume three servings of dairy per day (milk, yogurt, and cheese) before breakfast, lunch, and dinner. The control (low-dairy) group will continue their usual diet, keeping dairy intake to less than one serving per day.
Participants will have biweekly sessions with a registered dietitian to be guided to follow Canada's Food Guide, monitor their dietary intake and ensure compliance with their assigned group. In addition, they will visit the Nutrition Intervention Center at weeks 0, 12, and 24 for anthropometric and body composition assessments (weight, height, waist circumference, blood pressure, lean mass, and fat mass), resting metabolic rate, (gait speed, grip strength, and chair stand test just for older adults) and blood markers (fasting blood glucose, insulin, C-peptide, HbA1c, lipid profiles, and inflammatory markers). Each visit will take approximately 4 hours.
Read more
Before each visit, the participants will be asked to fast overnight for 12 hours, maintain their usual diet and sleep patterns, and avoid exercise and alcohol the day before. The participants will be compensated for their time and travel expenses.
Our secondary objective is to compare the effects of dairy and plant-based alternative products on blood sugar and appetite regulation in adolescents and older adults. Participants will be asked to come to the Nutrition Intervention Center on 3 separate occasions: once for an in-person screening lasting approximately 30 min and 2 times for study visits lasting approximately 2.5 hrs each. The entire study will take at least 2 weeks to complete. You will be asked to fast for 12 hrs (overnight) before each study visit. You will also be instructed to maintain the same dietary and sleep patterns and refrain from exercise and alcohol consumption on 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 your forearm to measure blood sugar, insulin, hormones, and amino acids. You will be compensated for your time and travel expenses.
- Conditions
- Dairy Consumption, Metabolic Health, Obesity Prevention
- Being tested
- Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study), Dairy (short-term study), Counselling to follow Canada's Food Guide (long-term study), Plant-based alternative (short-term study)
- Keywords
- Dairy intake, Obesity, Type2 Diabetes, HbA1c, BMI z-score, Insulin resistance, Adolescents, Seniors
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study)Other
Participants aged 15-18 and 60-80 years who are randomly assigned to the intervention group will follow Canada's Food Guide and consume 3 servings of dairy (milk, yogurt, cheese) per day for 24 weeks.
Dairy (short-term study)Other
The dairy products that participants will be required to consume include: 1) Trial 1: 2% cow's milk; 2) Trial 2: dairy yogurt.
Counselling to follow Canada's Food Guide (long-term study)Other
Participants will be instructed to follow Canada's Food Guide.
Plant-based alternative (short-term study)Other
The plant-based products that participants will be required to consume include: 1) Trial 1: soy beverage; 2) Trial 2: plant-based yogurt;
| Study group | Role | What they receive |
|---|---|---|
| High Dairy - Adolescents (long-term study) | Experimental | Participants in the intervention group will follow Canada's Food Guide and consume 3 servings of dairy per day. Receives: Other: Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study) |
| Low Dairy- Adolescents (long-term study) | Active comparator | Participants in the control group will adhere to Canada's Food Guide and keep their dairy intake to less than one serving per day. Receives: Other: Counselling to follow Canada's Food Guide (long-term study) |
| High Dairy - Seniors (long-term study) | Experimental | Participants in the intervention group will follow Canada's Food Guide and consume 3 servings of dairy per day. Receives: Other: Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study) |
| Low Dairy- Seniors (long-term study) | Active comparator | Participants in the control group will adhere to Canada's Food Guide and keep their dairy intake to less than one serving per day. Receives: Other: Counselling to follow Canada's Food Guide (long-term study) |
| Dairy arm - Adolescents (short-term study) | Experimental | Participants will consume 2 servings of dairy milk or yogurt. Receives: Other: Dairy (short-term study) |
| Plant-based alternative - Adolescents (short-term study) | Experimental | Participants will consume 2 servings of a commercially available soy milk or plant-based yogurt. Receives: Other: Plant-based alternative (short-term study) |
| Dairy arm - Seniors (short-term study) | Experimental | Participants will consume 2 servings of dairy milk or yogurt. Receives: Other: Dairy (short-term study) |
| Plant-based alternative - Seniors (short-term study) | Experimental | Participants will consume 2 servings of a commercially available soy milk or plant-based yogurt. Receives: Other: Plant-based alternative (short-term study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat Mass (kg)
Body Fat Mass (BFM) is the primary outcome in the long-term study of the senior group. It will be measured using bioelectrical impedance analysis (BIA).
Measured: BFM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).
Lean body mass (Kg)
Lean body mass (LBM) is the primary outcome in the long-term study of the senior group. It will be measured using bioelectrical impedance analysis (BIA).
Measured: LBM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).
Body Mass Index (BMI) z-score
BMI z-score, the primary outcome in the long-term study of the adolescent group, is an age- and sex-adjusted measure of BMI in adolescents. It will be calculated using height and weight measurements and interpreted using WHO growth charts and percentiles.
Measured: BMI z-score will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Blood Glucose (mmol/L) (short-term study)
Blood glucose, the primary outcome in the short-term studies of adolescents and seniors, will be measured via finger-prick using a glucometer at 0, 5, 20, 35, 50, 65, 95, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Secondary outcomes (27)
Fasting blood glucose (FBG) (mmol/L)
FBS will be measured to assess glycemic control in long-term studies of adolescents and seniors. It will be measured using a finger-prick blood sample and a glucometer after a 12-hour overnight fast.
Measured: FBS will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
HbA1c (%)
HbA1c measures average blood glucose levels over the past 2-3 months. It will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: HbA1c will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Insulin (µU/mL)
Insulin levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: Insulin will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
C-Peptide (pmol/L)
C-peptide levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: C-Peptide will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR will be calculated as (Fasting Insulin [µU/mL] × Fasting Glucose [mmol/L]) / 22.5 to assess insulin resistance in long-term studies of adolescents and seniors.
Measured: HOMA-IR will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Total cholesterol (TC) (mmol/L)
TC levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: TC will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Low-density lipoprotein cholesterol (LDL-C) (mmol/L)
LDL-C levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: LDL-C will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
High-density lipoprotein cholesterol (HDL-C) (mmol/L)
HDL-C levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: HDL-C will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Triglycerides (mmol/L)
Triglyceride levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: Triglycerides will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
C-Reactive protein (CRP) (mg/L)
CRP, a marker for assessing systemic inflammation, will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: CRP will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Interleukin-6 (IL-6) (pg/mL)
Interleukin-6 levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: Interleukin-6 will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Leptin (ng/mL)
Leptin levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: Leptin will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Adiponectin (µg/mL)
Adiponectin levels will be measured in plasma obtained through intravenous blood collection after a 12-hour overnight fast in long-term studies of adolescents and seniors.
Measured: Adiponectin will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Resting Metabolic Rate (RMR) (kcal/day)
RMR will be measured using indirect calorimetry after an overnight fast and at least 30 minutes of rest in a thermoneutral environment.
Measured: RMR will be measured at the beginning (week 0) and end of the study (week 24).
Blood pressure (BP) (mmHg)
Blood pressure will be measured in long-term studies of adolescents and seniors, using an automated sphygmomanometer after the participant has been seated and at rest for 10 minutes.
Measured: BP will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Waist circumference (WC) (cm)
WC will be measured in long-term studies of adolescents and seniors to assess abdominal adiposity using a standardized measuring tape at the midpoint between the lowest rib and the iliac crest while the participant is in a standing position.
Measured: WC will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Body Mass Index (BMI) (kg/m²)
BMI will be calculated to assess overall adiposity in seniors using weight and height measurements, applying the formula: BMI = weight (kg) / height (m²).
Measured: BMI will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Gait speed (m/s)
Gait speed will be assessed in a long-term study of seniors using a standardized 4-meter walk test as an indicator of physical function.
Measured: Gait speed will be measured at weeks 0, 6, 12, 18, and 24.
Grip strength (kg)
Grip strength will be assessed in the long-term study of seniors, using a hand dynamometer as a measure of muscle strength.
Measured: Grip strength will be measured at weeks 0, 6, 12, 18, and 24.
Chair stand test
The 30-second chair stand test will be used to assess lower-body strength in the long-term study of seniors. The number of completed stands within 30 seconds will be recorded.
Measured: The chair stand test will be performed at weeks 0, 6, 12, 18, and 24.
Urinary Urea Nitrogen (UUN)
Urinary urea nitrogen will be measured from a complete 24-hour urine collection in a subset of participants to estimate dietary protein intake and nitrogen balance in this long-term study of seniors.
Measured: Urinary urea nitrogen will be measured at baseline (week 0) and at week 24.
Insulin (µU/mL) (short-term study)
Insulin will be measured in the plasma through intravenous blood collection at 0, 35, 65, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
C-peptide (nmol/L) (short-term study)
C-peptide will be measured in the plasma through intravenous blood collection at 0, 35, 65, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Glucagon-like Peptide-1 (GLP-1) (short-term study)
GLP-1 will be measured in the plasma through intravenous blood collection at 0, 35, 65, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Amino acids (µmol/L) (short-term study)
Amino acid concentrations will be measured in the plasma through intravenous blood collection at 0, 35, 65, 125, and 145 minutes after treatment consumption.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Subjective Appetite (short-term study)
Subjective appetite will be assessed through Adaptive Visual Analogue Scales (AVAS) questionnaires completed at 0, 5, 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.
Measured: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Food intake (Kcal) (short-term study)
Ad libitum food intake (kcal) will be assessed during a standardized pizza meal provided 2 hours after treatment consumption, consumed over 20 minutes.
Measured: Assessed from 125 to 145 minutes following treatment consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dairy ConsumptionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G Harvey Anderson, Ph.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879652
- Sponsor's protocol ID
- 48001
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dairy Intake on Body Weight and Composition and Metabolic Health in Adolescents and Seniors
- ClinicalTrials.gov ID
- NCT06879652
- Acronym / sponsor ID
- 48001
- Conditions
- Dairy Consumption, Metabolic Health, Obesity Prevention
- Keywords
- Dairy intake, Obesity, Type2 Diabetes, HbA1c, BMI z-score, Insulin resistance, Adolescents, Seniors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine how regular dairy intake affects body weight, body composition, and metabolic health in overweight and obese adolescents (ages 15-18) and older adults (ages 60-80) over six months. We are inviting eligible individuals to participate in this study at the Nutrition Intervention Center, Department of Nutritional Sciences, University of Toronto. Participants will be randomly divided into two groups. The intervention (dairy) group will consume three servings of dairy per day (milk, yogurt, and cheese) before breakfast, lunch, and dinner. The control (low-dairy) group will continue their usual diet, keeping dairy intake to less than one serving per day.
Participants will have biweekly sessions with a registered dietitian to be guided to follow Canada's Food Guide, monitor their dietary intake and ensure compliance with their assigned group. In addition, they will visit the Nutrition Intervention Center at weeks 0, 12, and 24 for anthropometric and body composition assessments (weight, height, waist circumference, blood pressure, lean mass, and fat mass), resting metabolic rate, (gait speed, grip strength, and chair stand test just for older adults) and blood markers (fasting blood glucose, insulin, C-peptide, HbA1c, lipid profiles, and inflammatory markers). Each visit will take approximately 4 hours.
Before each visit, the participants will be asked to fast overnight for 12 hours, maintain their usual diet and sleep patterns, and avoid exercise and alcohol the day before. The participants will be compensated for their time and travel expenses.
Our secondary objective is to compare the effects of dairy and plant-based alternative products on blood sugar and appetite regulation in adolescents and older adults. Participants will be asked to come to the Nutrition Intervention Center on 3 separate occasions: once for an in-person screening lasting approximately 30 min and 2 times for study visits lasting approximately 2.5 hrs each. The entire study will take at least 2 weeks to complete. You will be asked to fast for 12 hrs (overnight) before each study visit. You will also be instructed to maintain the same dietary and sleep patterns and refrain from exercise and alcohol consumption on 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 your forearm to measure blood sugar, insulin, hormones, and amino acids. You will be compensated for your time and travel expenses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| High Dairy - Adolescents (long-term study) | Experimental | Other: Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study)Participants in the intervention group will follow Canada's Food Guide and consume 3 servings of dairy per day. |
| Low Dairy- Adolescents (long-term study) | Active comparator | Other: Counselling to follow Canada's Food Guide (long-term study)Participants in the control group will adhere to Canada's Food Guide and keep their dairy intake to less than one serving per day. |
| High Dairy - Seniors (long-term study) | Experimental | Other: Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study)Participants in the intervention group will follow Canada's Food Guide and consume 3 servings of dairy per day. |
| Low Dairy- Seniors (long-term study) | Active comparator | Other: Counselling to follow Canada's Food Guide (long-term study)Participants in the control group will adhere to Canada's Food Guide and keep their dairy intake to less than one serving per day. |
| Dairy arm - Adolescents (short-term study) | Experimental | Other: Dairy (short-term study)Participants will consume 2 servings of dairy milk or yogurt. |
| Plant-based alternative - Adolescents (short-term study) | Experimental | Other: Plant-based alternative (short-term study)Participants will consume 2 servings of a commercially available soy milk or plant-based yogurt. |
| Dairy arm - Seniors (short-term study) | Experimental | Other: Dairy (short-term study)Participants will consume 2 servings of dairy milk or yogurt. |
| Plant-based alternative - Seniors (short-term study) | Experimental | Other: Plant-based alternative (short-term study)Participants will consume 2 servings of a commercially available soy milk or plant-based yogurt. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Age 15-18 years old (adolescents) or 60-80 years old (seniors)
- BMI z-score >+1SD, <+2SD (adolescents) or BMI 25-34.9 kg/m2 (seniors)
- Waist circumference > 80 cm for women and > 94 cm for men (seniors)
- FBG 5.6-6.9 mmol/L (prediabetes)
- Willing to follow Canada's Food Guide
Key exclusion criteria (28 listed)
- Fasting BG ≥ 7 mmol/L
- Blood pressure systolic ≥ 130mmHg or diastolic ≥ 80mmHg (adolescents) or systolic ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg
- Smoking (tobacco and/or cannabis product use in the last 6 months)
- Thyroid problems
- History of CVDs, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorption syndrome, pancreatitis, gallbladder, or biliary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study)Participants aged 15-18 and 60-80 years who are randomly assigned to the intervention group will follow Canada's Food Guide and consume 3 servings of dairy (milk, yogurt, cheese) per day for 24 weeks. | Other | High Dairy - Adolescents (long-term study), High Dairy - Seniors (long-term study) |
| Dairy (short-term study)The dairy products that participants will be required to consume include: 1) Trial 1: 2% cow's milk; 2) Trial 2: dairy yogurt. | Other | Dairy arm - Adolescents (short-term study), Dairy arm - Seniors (short-term study) |
| Counselling to follow Canada's Food Guide (long-term study)Participants will be instructed to follow Canada's Food Guide. | Other | Low Dairy- Adolescents (long-term study), Low Dairy- Seniors (long-term study) |
| Plant-based alternative (short-term study)The plant-based products that participants will be required to consume include: 1) Trial 1: soy beverage; 2) Trial 2: plant-based yogurt; | Other | Plant-based alternative - Adolescents (short-term study), Plant-based alternative - Seniors (short-term study) |
Primary outcome
Body Fat Mass (kg)
Time frame: BFM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).
Body Fat Mass (BFM) is the primary outcome in the long-term study of the senior group. It will be measured using bioelectrical impedance analysis (BIA).
Lean body mass (Kg)
Time frame: LBM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).
Lean body mass (LBM) is the primary outcome in the long-term study of the senior group. It will be measured using bioelectrical impedance analysis (BIA).
Body Mass Index (BMI) z-score
Time frame: BMI z-score will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
BMI z-score, the primary outcome in the long-term study of the adolescent group, is an age- and sex-adjusted measure of BMI in adolescents. It will be calculated using height and weight measurements and interpreted using WHO growth charts and percentiles.
Blood Glucose (mmol/L) (short-term study)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Blood glucose, the primary outcome in the short-term studies of adolescents and seniors, will be measured via finger-prick using a glucometer at 0, 5, 20, 35, 50, 65, 95, 125, and 145 minutes after treatment consumption.
27 secondary outcomes
Fasting blood glucose (FBG) (mmol/L)
Time frame: FBS will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
HbA1c (%)
Time frame: HbA1c will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Insulin (µU/mL)
Time frame: Insulin will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
C-Peptide (pmol/L)
Time frame: C-Peptide will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: HOMA-IR will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Total cholesterol (TC) (mmol/L)
Time frame: TC will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Time frame: LDL-C will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
High-density lipoprotein cholesterol (HDL-C) (mmol/L)
Time frame: HDL-C will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Triglycerides (mmol/L)
Time frame: Triglycerides will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
C-Reactive protein (CRP) (mg/L)
Time frame: CRP will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Interleukin-6 (IL-6) (pg/mL)
Time frame: Interleukin-6 will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Leptin (ng/mL)
Time frame: Leptin will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Adiponectin (µg/mL)
Time frame: Adiponectin will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Resting Metabolic Rate (RMR) (kcal/day)
Time frame: RMR will be measured at the beginning (week 0) and end of the study (week 24).
Blood pressure (BP) (mmHg)
Time frame: BP will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Waist circumference (WC) (cm)
Time frame: WC will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Body Mass Index (BMI) (kg/m²)
Time frame: BMI will be measured at the beginning (week 0), midpoint (week 12), and end of the study (week 24).
Gait speed (m/s)
Time frame: Gait speed will be measured at weeks 0, 6, 12, 18, and 24.
Grip strength (kg)
Time frame: Grip strength will be measured at weeks 0, 6, 12, 18, and 24.
Chair stand test
Time frame: The chair stand test will be performed at weeks 0, 6, 12, 18, and 24.
Urinary Urea Nitrogen (UUN)
Time frame: Urinary urea nitrogen will be measured at baseline (week 0) and at week 24.
Insulin (µU/mL) (short-term study)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
C-peptide (nmol/L) (short-term study)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Glucagon-like Peptide-1 (GLP-1) (short-term study)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Amino acids (µmol/L) (short-term study)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Subjective Appetite (short-term study)
Time frame: Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.
Food intake (Kcal) (short-term study)
Time frame: Assessed from 125 to 145 minutes following treatment consumption.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Dairy Consumption
Recruiting
Fermented Dairy Product and Bifidobacterium Diversity
A03 - Digestive System, B03 - Bacteria
Active, not recruitingObservational study
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2
Cancer, Breast, Cancer, Colorectal
Active, not recruiting
Determine How Consumption of Dairy Fat Fractions Rich in Phospholipids and Proteins Influence Inflammation in the Fed State-Phase 1
Metabolic Syndrome, Obesity
Active, not recruiting
Determine How Consumption of Dairy Fat as Cheese Influences Inflammation-Phase 2
Metabolic Syndrome, Obesity
Recruiting
Impact of Dairy Integration Into Canadian Food Guide on Gut Health
Gut Epithelial Permeability, Gut Microbiota Composition and Diversity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
G Harvey Anderson, Ph.D. principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study), Dairy (short-term study) and Counselling to follow Canada's Food Guide (long-term study) in people with Dairy Consumption and Metabolic Health, run by University of Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shekoufeh Salamat, Ph.D. (647-657-5242, s.salamat@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat Mass (kg) (time frame: BFM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.