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New treatment option 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 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.
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
- (long-term Study):
- 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)
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
- (long-term Study):
- 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)
- Restrained eating, identified by a score of ≥11 on the Eating Habits Questionnaire Inclusion Criteria (short-term study):
- 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 (short-term 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's taking place
- Toronto, Ontario, Canada
- Toronto, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Toronto, Ontario, Canada; Toronto, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.