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Whole vs. Nonfat Milk Consumption and Body Composition in Children

This study is looking at how drinking whole milk compared to nonfat milk affects body composition (like fat mass) in children aged 9 to 12 years old. Researchers want to see if whole milk leads to less weight gain and lowers the risk factors for heart disease and diabetes. You might be able to join if you are between 9 and 12, have a Body Mass Index (BMI) at or above the 75th percentile for your age and sex, and live in the Greater Boston area. The study aims to enroll 200 children. The main goal is to see how fat mass changes over 12 months. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 200 participants. Participants will be assigned to either receive whole milk or nonfat milk.
What's involved
Participants will receive weekly home delivery of milk, daily text messages, and monthly virtual visits. Fat mass will be measured at the start and end of the 12-month trial.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, from the start of the trial until the end.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05464186

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children

Recruiting
NAAges 9–12InterventionalPrevention
Boston Children's Hospital
~200 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Whole milkNonfat milk

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fat mass
Measured over Change from start of trial (time of randomization) through end of trial (12 months)

Conditions

Obesity
Diabetes
Cardiovascular Diseases

Explore related trials

Cardiovascular DisorderDiabetes MellitusObesity

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Cara B Ebbeling, PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
  • David S Ludwig, MD, PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

Donna L Lesperance, MA, MPH
[email protected]
617-919-7305
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 9 to 12 years
BMI ≥75th percentile for sex and age
Residence in the Greater Boston catchment area

Exclusion

Aversion to nonfat or whole milk
Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided)
Plans to move away from the Greater Boston catchment area during the study period
Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation)
Change in body weight exceeding 10% during prior year
Recent adherence to a special diet
Chronic use of any medication or dietary supplement that could affect study outcomes
Another member of the family (first degree relative) or household participating in the study

What this trial measures

  • Fat massChange from start of trial (time of randomization) through end of trial (12 months)

    Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)