Clinical trial for Dairy Consumption
Official title The Effect of Dairy Intake on Body Weight and Composition and Metabolic Health in Adolescents and Seniors
ClinicalTrials.gov ID: NCT06879652
What this study is testing
- What it's testing
- The study wants to see whether eating three servings of dairy each day changes body weight, body composition, and metabolic health compared with a low‑dairy diet.
- Who it's for
- Overweight or obese adolescents aged 15‑18 and adults aged 60‑80 who can attend study visits in Toronto.
- What's involved
- You will be assigned to eat three servings of dairy daily or keep dairy under one serving, meet a dietitian every two weeks, and attend three clinic visits for measurements, blood tests, and questionnaires while fasting overnight before each visit.
- Time commitment
- The trial lasts about six months with visits at the start, 12 weeks, and 24 weeks, each lasting 2‑4 hours, plus biweekly dietitian sessions.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- Presence of gastrointestinal disorder or surgeries within the past year.
See the full eligibility criteria
- 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.
- 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...
- 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.
- 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)
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.