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

NCT ID: NCT06879652

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to examine how regular dairy intake affects body weight, body composition, and metabolic health in overweight and prediabetic adolescents (ages 14-17) and older adults (ages 60-75) over a six-month period. We are inviting eligible individuals to participate in this study at the Nutrition Intervention Center, Department of Nutritional Sciences, University of Toronto, St. George campus. Participants will be randomly divided into two groups. The intervention (high-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 less than one serving per day.

Participants will have biweekly sessions with a registered dietitian to monitor their dietary intake and ensure compliance with their assigned group. In addition, they will visit the Nutrition Intervention Center at week 0, week 12, and week 24 for anthropometric and body composition assessments (weight, height, waist circumference, blood pressure, lean mass, fat mass), glycemic and metabolic markers (fasting blood glucose, insulin, HbA1c, lipid profiles in seniors, and appetite hormones in adolescents). Each assessment visit will take approximately 4 hours.

Before each visit, you will be asked to fast for 12 hours overnight, maintain your usual diet and sleep patterns, and avoid exercise and alcohol consumption the day before. Your participation in this study will help us better understand the role of dairy in metabolic health and may contribute to improved dietary recommendations for adolescents and older adults. You will be compensated for your time and travel expenses.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dairy Consumption Metabolic Health Obesity Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm, Dairy Group- Adolescents

The participants in the intervention group will consume 3 servings of dairy per day.

Group Type EXPERIMENTAL

Increasing Dairy intake

Intervention Type OTHER

The prediabetic and overweight participants aged 14-17 and 60-75 years consuming ≤1 serving of dairy per day who are assigned to the intervention group will consume 3 servings of dairy (milk, yogurt, cheese) before each meal throughout a day for 24 weeks.

Control arm, Low Dairy- Adolescents

The participants in the control group will be asked to maintain their usual diet and dairy intake, involving consuming ≤1 serving of dairy per day.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention arm, Dairy Group- Seniors

The participants in the intervention group will consume 3 servings of dairy per day.

Group Type EXPERIMENTAL

Increasing Dairy intake

Intervention Type OTHER

The prediabetic and overweight participants aged 14-17 and 60-75 years consuming ≤1 serving of dairy per day who are assigned to the intervention group will consume 3 servings of dairy (milk, yogurt, cheese) before each meal throughout a day for 24 weeks.

Control arm, Low Dairy- Seniors

The participants in the control group will be asked to maintain their usual diet and dairy intake, involving consuming ≤1 serving of dairy per day.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Increasing Dairy intake

The prediabetic and overweight participants aged 14-17 and 60-75 years consuming ≤1 serving of dairy per day who are assigned to the intervention group will consume 3 servings of dairy (milk, yogurt, cheese) before each meal throughout a day for 24 weeks.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 14-17 years old (adolescents) or 60-75 years old (seniors)
* BMI z-score \>+1SD, \<+2SD (adolescents) or BMI 25-30 kg/m2 (seniors)
* Waist circumference \> 88 cm for women and \> 102 cm for men (seniors)
* FBG 5.6-6.9 mmol/L (prediabetes)
* Consumes ≤1 serving of dairy per day
* Willing to maintain habitual diet, physical activity, and body weight throughout the study.
* Willing to maintain current dietary supplement use throughout the study. On the first day, the participants agree not to take any dietary supplements until the completion of the study.
* Willing to abstain from alcohol consumption for 24 hours prior to all test visits.
* Willing to avoid vigorous physical activity for 24 hours prior to all test visits.
* Understands the study procedures and is willing to provide informed consent by parent/guardian and assent by participant to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion Criteria

* Fasting BG ≥ 7mmol/L
* Blood pressure systolic ≥ 130mmHg or diastolic ≥ 80mmHg (adolescents) or systolic ≥ 160 mmHg or diastolic pressure ≥ 100 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).
* History of childhood obesity
* 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 \>10 lbs. 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

G. Harvey Anderson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

G Harvey Anderson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Nutritional Sciences

Toronto, Ontario, Canada

Site Status RECRUITING

Nutrition Intervention Center

Toronto, , Canada

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shekoufeh Salamat, Ph.D.

Role: CONTACT

647-657-5242

Corrina Zhou, MSc

Role: CONTACT

416-946-3802

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shekoufeh SS Salamat, Ph.D.

Role: primary

416-946-3802

Corrina CZ Zhou, Master's degree

Role: backup

416-946-3802

Shekoufeh Salamat, Ph.D.

Role: primary

647-657-5242

Corrina Zhou, MSc

Role: backup

416-946-3802

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

48001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Breakfast for Young Females
NCT04518605 COMPLETED NA
DAWL (Dairy and Weight Loss) Study
NCT01337895 WITHDRAWN PHASE4