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

Not Applicable

Recruiting

• Conditions: Obesity; Diabetes; Cardiovascular Diseases

• Registration Number: NCT05464186
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-6-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria:<br><br> - Aged 9 to 12 years<br><br> - BMI =75th percentile for sex and age<br><br> - Residence in the Greater Boston catchment area<br><br>Exclusion Criteria:<br><br> - Aversion to nonfat or whole milk<br><br> - Physician diagnosis of major medical illness, eating disorder, or milk allergy<br> (lactose intolerance not exclusionary as lactase treated milk can be provided)<br><br> - Abnormal laboratory tests: HgA1c, TSH, hematocrit, BUN, creatinine, ALT (>1.5 normal<br> upper limit)<br><br> - Plans to move away from the Greater Boston catchment area during the study period<br><br> - Plans to be away from home for =5 weeks during the study period (e.g., extended<br> summer vacation)<br><br> - Change in body weight exceeding 10% during prior year<br><br> - Recent adherence to a special diet<br><br> - Chronic use of any medication or dietary supplement that could affect study outcomes<br><br> - Another member of the family (first degree relative) or household participating in<br> the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fat mass

Secondary Outcome Measures

Name	Time	Method
Lean body mass;Percent body fat;Height;Body mass index (BMI);Leptin;Ghrelin;Insulin-like growth factor-1 (IGF-1);Insulin-like growth factor-binding protein 3 (IGF-BP3);Lipoprotein insulin resistance (LPIR);Triglyceride-rich lipoprotein particle (TRL-P) size;High-density lipoprotein particle (HDL-P) size;Low-density lipoprotein particle (LDL-P) size;Sum of large and very large TRL-P concentration;Large HDL-P concentration;Small LDL-P concentration;Large LDL-P concentration;Triglycerides (TG);High-density lipoprotein cholesterol (HDL-C);Low-density lipoprotein cholesterol (LDL-C);Glucose;Insulin;Insulin resistance;Adiponectin - total and high molecular weight;Hemoglobin A1c (HgA1c);High-sensitivity C-reactive protein (hsCRP);Interleukin-6 (IL-6);Fibrinogen;Plasminogen activator inhibitor-1 (PAI-1);Systolic blood pressure;Diastolic blood pressure