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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.


Obesity, Diabetes, Cardiovascular Diseases

Recruitment Status


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≥85th 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.

Eligibility Criteria

Inclusion Criteria:

Aged 9 to 12 years
BMI ≥85th 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


Intervention Type

Intervention Name


Whole milk


Nonfat milk


Not Applicable



Min Age

9 Years

Max Age

12 Years

Download Date

June 5, 2023

Principal Investigator

Cara B Ebbeling, PhD and David S Ludwig, MD, PhD

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Primary Contact Information

Donna L Lesperance, MA, MPH

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For more information on this trial, visit


For more information and to contact the study team:

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children NCT05464186 Donna L Lesperance, MA, MPH