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

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This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.

Conditions:

🦠 Obesity 🦠 Diabetes 🦠 Cardiovascular Diseases

🗓️ Study Start (Actual) 28 December 2022

🗓️ Primary Completion (Estimated) October 2025

✅ Study Completion (Estimated) October 2025

👥 Enrollment (Estimated) 200

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 9 Years to 12 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 27 June 2022
First Submitted that Met QC Criteria 15 July 2022
First Posted 19 July 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 31 October 2023
Last Update Posted 2 November 2023
Last Verified October 2023