Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children
Launched by BOSTON CHILDREN'S HOSPITAL · Jul 15, 2022
Trial Information
Current as of August 20, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how drinking whole milk compares to nonfat milk in affecting the body composition and health risks associated with obesity, diabetes, and heart diseases in children. The study aims to see which type of milk might be better for children's health and overall diet quality. They are currently looking for children aged 9 to 12 years who are living in the Greater Boston area and have a higher body weight compared to their peers.
To participate, children need to have a body mass index (BMI) at or above the 75th percentile for their age and sex. However, they cannot have any serious medical conditions, significant eating disorders, or allergies to milk. If eligible, participants will drink either whole or nonfat milk and will be monitored for changes in their health. It's important to note that if a family member is already part of the study, that child cannot join. This trial provides an opportunity to help researchers understand the best dietary practices for children's health.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Aged 9 to 12 years
- • BMI ≥75th percentile for sex and age
- • Residence in the Greater Boston catchment area
- Exclusion Criteria:
- • 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)
- • Abnormal laboratory tests: HgA1c, TSH, hematocrit, BUN, creatinine, ALT (\>1.5 normal upper limit)
- • 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
About Boston Children's Hospital
Boston Children's Hospital is a leading pediatric healthcare institution renowned for its commitment to advancing child health through innovative research and exceptional clinical care. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in pediatric medicine to conduct rigorous and ethically sound research studies aimed at improving treatment options and outcomes for children. With a collaborative approach that integrates cutting-edge technology and multidisciplinary teams, Boston Children's Hospital is dedicated to translating scientific discoveries into practical applications that enhance the well-being of young patients and their families.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Patients applied
Trial Officials
Cara B Ebbeling, PhD
Principal Investigator
Boston Children's Hospital
David S Ludwig, MD, PhD
Principal Investigator
Boston Children's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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