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Dairy

Whole vs Nonfat Milk for Childhood Obesity

N/A
Recruiting
Led By David S Ludwig, MD, PhD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 9 to 12 years
BMI ≥75th percentile for sex and age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from start of trial (time of randomization) through end of trial (12 months)
Awards & highlights

Study Summary

This trial will compare the effects of drinking whole milk to drinking nonfat milk on body fat, heart disease risk factors, and diet quality.

Who is the study for?
This trial is for children aged 9 to 12 with a BMI in the top 15% for their age and sex, living near Boston. It's not for those planning to move or be away long-term, with certain abnormal lab tests, major weight changes recently, on special diets, if someone at home is also in the study, or with milk allergies or serious health issues.Check my eligibility
What is being tested?
The study compares the effects of drinking whole milk versus nonfat milk on kids' body fat and muscle composition. It also looks at how these milks affect risks for heart disease, obesity-related conditions like diabetes, and overall diet quality.See study design
What are the potential side effects?
Since this trial involves consumption of whole vs. nonfat milk as its intervention rather than medication or medical procedures, side effects are minimal but could include digestive discomfort depending on individual lactose tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 9 and 12 years old.
Select...
My BMI is in the top 25% for my age and sex.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from start of trial (time of randomization) through end of trial (12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from start of trial (time of randomization) through end of trial (12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fat mass
Secondary outcome measures
Adiponectin - total and high molecular weight
Body mass index (BMI)
Diastolic blood pressure
+27 more
Other outcome measures
Alternative Healthy Eating Index (AHEI)
Food and beverage intake pattern
Heptadecanoic acid (C17:0)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Whole milkExperimental Treatment1 Intervention
3 cups a day of whole milk for 1 year
Group II: Nonfat milkExperimental Treatment1 Intervention
3 cups a day of nonfat milk for 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Whole milk
2013
N/A
~30

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
758 Previous Clinical Trials
5,579,110 Total Patients Enrolled
23 Trials studying Obesity
5,980 Patients Enrolled for Obesity
David S Ludwig, MD, PhDPrincipal InvestigatorBoston Children's Hospital
15 Previous Clinical Trials
1,104 Total Patients Enrolled
11 Trials studying Obesity
991 Patients Enrolled for Obesity
Cara B Ebbeling, PhDPrincipal InvestigatorBoston Children's Hospital
9 Previous Clinical Trials
723 Total Patients Enrolled
8 Trials studying Obesity
723 Patients Enrolled for Obesity

Media Library

Nonfat Milk (Dairy) Clinical Trial Eligibility Overview. Trial Name: NCT05464186 — N/A
Obesity Research Study Groups: Whole milk, Nonfat milk
Obesity Clinical Trial 2023: Nonfat Milk Highlights & Side Effects. Trial Name: NCT05464186 — N/A
Nonfat Milk (Dairy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464186 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to join the research experiment?

"This clinical trial has a target sample size of 200 children aged between 9 and 12, with obesity as measured by their BMI being equal to or higher than the 85th percentile for age and sex. Furthermore, participants must consume no more than 1.5 cups of milk per day on average, while residing in Crescent Ridge Dairy's catchment area."

Answered by AI

Is the age criteria for enrolment into this trial limited to individuals aged twenty or older?

"According to the study parameters, children aged 9-12 are accepted into this clinical trial."

Answered by AI

Are there any vacant spots available for participants in this clinical trial?

"Contrary to what is posted on clinicaltrials.gov, this medical study isn't accepting participants at the moment. This trial was initially advertised in October 1st 2022 and has been revised recently on August 5th 2022. While there are no vacancies presently available for this particular research project, an abundance of other experiments have openings right now with a total of 1505 studies recruiting patients currently."

Answered by AI
~109 spots leftby Oct 2025