Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children
- Conditions
- Cardiovascular DiseasesDiabetesObesity
- Interventions
- Behavioral: Nonfat milkBehavioral: Whole milk
- Registration Number
- NCT05464186
- Lead Sponsor
- Boston Children's Hospital
- Brief Summary
This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.
- Detailed Description
Background The optimal type of milk is a topic of much debate. Several recent observational studies indicate that consuming whole (full-fat), compared to reduced-fat milk, is associated with less weight gain and decreased cardiometabolic disease risk. The observed beneficial effect of consuming whole milk on body weight may be due to its greater satiety value, leading to consumption of fewer calories from other lower quality (e.g., sugary) foods. Mechanistic studies indicate that substitution of carbohydrate with certain saturated fatty acids in milk increases low-density lipoprotein cholesterol (LDL-C). However, this increase has been attributed to large, buoyant particles that are less atherogenic than small, dense particles; is accompanied by an increase in high-density lipoprotein cholesterol (HDL-C); and may not elevate overall risk compared to carbohydrate.
Specific Aims and Hypotheses
* To examine the effects of milk consumption on body composition (Aim #1) and cardiometabolic disease risk factors (Aim #2). Primary Hypothesis. Consuming whole milk will result in less weight gain compared to consuming nonfat milk. Secondary hypothesis. Consuming whole milk will decrease cardiometabolic disease risk compared to consuming nonfat milk.
* To explore the effects of milk consumption on dietary quality (Aim #3). Exploratory hypothesis. Consuming whole milk will improve overall dietary quality by displacing lower quality foods compared to consuming nonfat milk, particularly among children with low baseline dietary quality.
Design Randomized Controlled Trial. Participants (N=200, aged 9 to 12 years, BMI≥75th percentile) will be randomly assigned for 1 year to receive: 1) Whole milk, 3 cups/d or 2) Nonfat milk, 3 cups/d. To promote adherence to the interventions, the investigators will rely on home delivery of milk using methods consistent with previous successful studies.
Study Outcomes The primary outcome is change in fat mass measured by air displacement plethysmography (BodPod) at 3 time points (baseline and 6 and 12 months). To evaluate cardiometabolic disease risk factors, the investigators will obtain a plasma MetaboProfile®(LabCorp) that includes lipoprotein particle sizes and subfraction concentrations, novel measures of insulin-resistant dyslipoproteinemia and inflammation, and a conventional lipid profile. The investigators will also measure blood pressure.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Aged 9 to 12 years
- BMI ≥75th percentile for sex and age
- Residence in the Greater Boston catchment area
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nonfat milk Nonfat milk 3 cups a day of nonfat milk for 1 year Whole milk Whole milk 3 cups a day of whole milk for 1 year
- Primary Outcome Measures
Name Time Method Fat mass Change 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)
- Secondary Outcome Measures
Name Time Method Height Change from start of trial (time of randomization) through end of trial (12 months) Linear growth
Body mass index (BMI) Change from start of trial (time of randomization) through end of trial (12 months) Weight in kg divided by height in meters squared
Lipoprotein insulin resistance (LPIR) Change from start of trial (time of randomization) through end of trial (12 months) Main outcome for Specific Aim #2; a 6-component weighted score of triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (sum of large and very large TRL-P, large HDL-P, small LDL-P), measured by nuclear magnetic resonance spectroscopy
Low-density lipoprotein particle (LDL-P) size Change from start of trial (time of randomization) through end of trial (12 months) Measured by nuclear magnetic resonance spectroscopy
Small LDL-P concentration Change from start of trial (time of randomization) through end of trial (12 months) Measured by nuclear magnetic resonance spectroscopy
Large LDL-P concentration Change from start of trial (time of randomization) through end of trial (12 months) Measured by nuclear magnetic resonance spectroscopy
High-density lipoprotein cholesterol (HDL-C) Change from start of trial (time of randomization) through end of trial (12 months) Part of conventional lipid profile
Interleukin-6 (IL-6) Change from start of trial (time of randomization) through end of trial (12 months) Protein which stimulates synthesis of hsCRP, measured by ELISA assay
Fibrinogen Change from start of trial (time of randomization) through end of trial (12 months) Protein involved in blood clotting, measured by immunoturbidimetric assay
Systolic blood pressure Change from start of trial (time of randomization) through end of trial (12 months) Measured by auscultation
Lean body mass Change from start of trial (time of randomization) through end of trial (12 months) Measured by air displacement plethysmography (BodPod)
Percent body fat Change from start of trial (time of randomization) through end of trial (12 months) Measured by air displacement plethysmography (BodPod)
Leptin Change from start of trial (time of randomization) through end of trial (12 months) "Satiety" hormone, released by fat cells, measured by ELISA assay
Ghrelin Change from start of trial (time of randomization) through end of trial (12 months) "Hunger" hormone, released primarily in the stomach, measured by ELISA assay
Triglyceride-rich lipoprotein particle (TRL-P) size Change from start of trial (time of randomization) through end of trial (12 months) Measured by nuclear magnetic resonance spectroscopy
High-density lipoprotein particle (HDL-P) size Change from start of trial (time of randomization) through end of trial (12 months) Measured by nuclear magnetic resonance spectroscopy
Sum of large and very large TRL-P concentration Change from start of trial (time of randomization) through end of trial (12 months) Measured by nuclear magnetic resonance spectroscopy
Large HDL-P concentration Change from start of trial (time of randomization) through end of trial (12 months) Measured by nuclear magnetic resonance spectroscopy
Low-density lipoprotein cholesterol (LDL-C) Change from start of trial (time of randomization) through end of trial (12 months) Part of conventional lipid profile
Glucose Change from start of trial (time of randomization) through end of trial (12 months) Measured enzymatically using hexokinase method
Insulin Change from start of trial (time of randomization) through end of trial (12 months) Measured by electrochemiluminescence immunoassay
Hemoglobin A1c (HgA1c) Change from start of trial (time of randomization) through end of trial (12 months) Marker of blood glucose control, measured using a system based turbidimetric immunoinhibition
Diastolic blood pressure Change from start of trial (time of randomization) through end of trial (12 months) Measured by auscultation
Insulin-like growth factor-1 (IGF-1) Change from start of trial (time of randomization) through end of trial (12 months) Indicator of growth hormone action, measured by ELISA assay
Insulin-like growth factor-binding protein 3 (IGF-BP3) Change from start of trial (time of randomization) through end of trial (12 months) Measured by ELISA assay
Triglycerides (TG) Change from start of trial (time of randomization) through end of trial (12 months) Part of conventional lipid profile
Insulin resistance Change from start of trial (time of randomization) through end of trial (12 months) Measured by homeostasis model assessment (HOMA), using fasting glucose and insulin concentrations
Plasminogen activator inhibitor-1 (PAI-1) Change from start of trial (time of randomization) through end of trial (12 months) Protein involved in blood clotting, measured by ELISA assay
Adiponectin - total and high molecular weight Change from start of trial (time of randomization) through end of trial (12 months) Hormone released from fat cells, promotes insulin sensitivity and helps regulate blood glucose, measured by ELISA assay
High-sensitivity C-reactive protein (hsCRP) Change from start of trial (time of randomization) through end of trial (12 months) Indicator of chronic inflammation, measured by immunoturbidimetric assay
Trial Locations
- Locations (1)
New Balance Foundation Obesity Prevention Center
🇺🇸Boston, Massachusetts, United States