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Recruiting
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Comparing 8 approaches for dairy consumption

Official title: The Effect of Dairy Intake on Body Weight and Composition and Metabolic Health in Adolescents and Seniors

Condition: Dairy ConsumptionSponsor: University of TorontoTarget enrollment: 240
  • 8 groups
  • 2 sites in Toronto
  • Recruiting
Nutrition Intervention Center, TorontoDepartment of Nutritional Sciences, Toronto, Ontario

Interventions (4)

  • Other intervention

    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 intervention

    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 intervention

    Counselling to follow Canada's Food Guide (long-term study)

    Participants will be instructed to follow Canada's Food Guide.

Canadian Sites (2)

1 of 2 recruiting

  • Department of Nutritional Sciences

    Toronto, Ontario

    Recruiting
  • Nutrition Intervention Center

    Toronto

    Not yet recruiting

Eligibility Criteria

See who this study is looking for48 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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)
  • +FBG 5.6-6.9 mmol/L (prediabetes)
  • +(long-term Study):
  • +Waist circumference \> 80 cm for women and \> 94 cm for men (seniors)
  • +Willing to follow Canada's Food Guide
  • +Willing to maintain current dietary supplement use throughout the study.
  • +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → by the parent/guardian and assent by participant to participate in the study and authorization to release relevant protected health information to the study investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.

Exclusion

  • 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)
  • Known intolerance, sensitivity, or allergy to dairy, gluten, or any other study treatments.
  • Lactose intolerance and/or allergies, intolerances, or sensitivities to study treatments
  • Fasting BG ≥ 7 mmol/L
  • Blood pressure systolic ≥ 130mmHg or diastolic ≥ 80mmHg (adolescents) or systolic ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg
  • 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.
  • Use of the prescription or non-prescription drugs, herbal or nutritional supplements known to affect the outcome of the study as per the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment (including prebiotics and probiotics).
  • Unwillingness or inability to comply with the experimental procedures
  • 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
  • Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → (short-term study):
  • 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the study, and authorizes release of relevant protected health information to the study investigator.
  • Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → (short-term study):
  • Thyroid problems
  • 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
  • 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
  • Known to be pregnant, lactating, or not postmenopausal for at least a year and/or is taking hormonal treatments
  • Smoking (tobacco and/or cannabis product use in the last 6 months)
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to prevent a condition from developing.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 8 groups in this study.

Groups A and C receive Counselling to follow Canada's Food Guide and 3 daily servings of Dairy (long-term study).

Registry label: A: High Dairy - Adolescents (long-term study) · C: High Dairy - Seniors (long-term study)

Groups B and D, the comparison group, receive Counselling to follow Canada's Food Guide (long-term study).

Registry label: B: Low Dairy- Adolescents (long-term study) · D: Low Dairy- Seniors (long-term study)

Groups E and G receive Dairy (short-term study).

Registry label: E: Dairy arm - Adolescents (short-term study) · G: Dairy arm - Seniors (short-term study)

Groups F and H receive Plant-based alternative (short-term study).

Registry label: F: Plant-based alternative - Adolescents (short-term study) · H: Plant-based alternative - Seniors (short-term study)

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 14 years to 80 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 240 people.

The study is currently expected to finish around June 2028.

The main measurement is taken over: BFM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Body Fat Mass (kg) — measured over BFM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).

Lean body mass (Kg) — measured over LBM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24).

Body Mass Index (BMI) z-score — measured over 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) — measured over Over 145 minutes after treatment consumption at each session, for a total of 2 weekly sessions.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06879652 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About 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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About 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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Counselling to follow Canada's Food Guide (long-term study)Other

Participants will be instructed to follow Canada's Food Guide.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About 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;

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 14 years to 80 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 14 years to 80 years.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BFM will be measured at weeks 0, 6, 12, 18, and the end of the study (week 24)..

The study as a whole is currently expected to finish around 2028-06.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 240 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 2 locations, including: Toronto, Canada; Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.