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

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Obesity; Diabetes
• Intervention / Treatment: Behavioral: Whole milk; Behavioral: Nonfat milk

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.
• (Ancillary Study) To evaluate the effects of milk consumption on risk and prevalence of dental caries.

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.

For the Ancillary Study, outcomes include salivary cariogenicity (pH, flow, and buffering capacity); caries prevalence; dietary quality (cariogenic potential); and serum 25-hydroxyvitamin D.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donna L Lesperance, MA, MPH; Phone Number: 617-919-7305; Email: Donna.Lesperance@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • New Balance Foundation Obesity Prevention Center
      • Contact: Donna L Lesperance, MA, MPH; Phone Number: 617-919-7305; Email: Donna.Lesperance@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

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)
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole milk; 3 cups a day of whole milk for 1 year	Behavioral: Whole milk; Weekly home delivery of whole milk, daily text messages, monthly virtual visits
Experimental: Nonfat milk; 3 cups a day of nonfat milk for 1 year	Behavioral: Nonfat milk; Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat mass	Primary outcome for the overall study, main outcome for Specific Aim #1, measured by air displacement plethysmography (BodPod)	Change from start of trial (time of randomization) through end of trial (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lean body mass	Measured by air displacement plethysmography (BodPod)	Change from start of trial (time of randomization) through end of trial (12 months)
Percent body fat	Measured by air displacement plethysmography (BodPod)	Change from start of trial (time of randomization) through end of trial (12 months)
Height	Linear growth	Change from start of trial (time of randomization) through end of trial (12 months)
Body mass index (BMI)	Weight in kg divided by height in meters squared	Change from start of trial (time of randomization) through end of trial (12 months)
Leptin	"Satiety" hormone, released by fat cells, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Ghrelin	"Hunger" hormone, released primarily in the stomach, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Insulin-like growth factor-1 (IGF-1)	Indicator of growth hormone action, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Insulin-like growth factor-binding protein 3 (IGF-BP3)	Measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Lipoprotein insulin resistance (LPIR)	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	Change from start of trial (time of randomization) through end of trial (12 months)
Triglyceride-rich lipoprotein particle (TRL-P) size	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
High-density lipoprotein particle (HDL-P) size	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Low-density lipoprotein particle (LDL-P) size	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Sum of large and very large TRL-P concentration	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Large HDL-P concentration	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Small LDL-P concentration	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Large LDL-P concentration	Measured by nuclear magnetic resonance spectroscopy	Change from start of trial (time of randomization) through end of trial (12 months)
Triglycerides (TG)	Part of conventional lipid profile	Change from start of trial (time of randomization) through end of trial (12 months)
High-density lipoprotein cholesterol (HDL-C)	Part of conventional lipid profile	Change from start of trial (time of randomization) through end of trial (12 months)
Low-density lipoprotein cholesterol (LDL-C)	Part of conventional lipid profile	Change from start of trial (time of randomization) through end of trial (12 months)
Glucose	Measured enzymatically using hexokinase method	Change from start of trial (time of randomization) through end of trial (12 months)
Insulin	Measured by electrochemiluminescence immunoassay	Change from start of trial (time of randomization) through end of trial (12 months)
Insulin resistance	Measured by homeostasis model assessment (HOMA), using fasting glucose and insulin concentrations	Change from start of trial (time of randomization) through end of trial (12 months)
Adiponectin - total and high molecular weight	Hormone released from fat cells, promotes insulin sensitivity and helps regulate blood glucose, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Hemoglobin A1c (HgA1c)	Marker of blood glucose control, measured using a system based turbidimetric immunoinhibition	Change from start of trial (time of randomization) through end of trial (12 months)
High-sensitivity C-reactive protein (hsCRP)	Indicator of chronic inflammation, measured by immunoturbidimetric assay	Change from start of trial (time of randomization) through end of trial (12 months)
Interleukin-6 (IL-6)	Protein which stimulates synthesis of hsCRP, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Fibrinogen	Protein involved in blood clotting, measured by immunoturbidimetric assay	Change from start of trial (time of randomization) through end of trial (12 months)
Plasminogen activator inhibitor-1 (PAI-1)	Protein involved in blood clotting, measured by ELISA assay	Change from start of trial (time of randomization) through end of trial (12 months)
Systolic blood pressure	Measured by auscultation	Change from start of trial (time of randomization) through end of trial (12 months)
Diastolic blood pressure	Measured by auscultation	Change from start of trial (time of randomization) through end of trial (12 months)
Salivary cariogenicity	(Ancillary Study) Risk for dental caries (cavities), measured using the GC Dental America Saliva-Check Buffer Kit (pH, flow, and buffering capacity)	Change from start of trial (time of randomization) through end of trial (12 months)
Caries prevalence	(Ancillary Study) Assessed by clinical examination and digital radiograph (x-rays)	Difference between start of trial (time of randomization) and end of trial (12 months)
Serum 25-hydroxyvitamin D [25(OH)D]	(Ancillary Study) Measured by a competitive electrochemiluminescence immunoassay	Change from start of trial (time of randomization) through end of trial (12 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pentadecanoic acid (C15:0)	Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat	Change from start of trial (time of randomization) through end of trial (12 months)
Heptadecanoic acid (C17:0)	Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat	Change from start of trial (time of randomization) through end of trial (12 months)
trans Palmitoleic acid (tC16:1ω-7)	Process measure, biomarker of milk fast consumption, fatty acid in red blood cell membranes which comes primarily from milk fat	Change from start of trial (time of randomization) through end of trial (12 months)
Alternative Healthy Eating Index (AHEI)	Main outcome for Specific Aim #3, calculated using data from 24-hour dietary recalls	Change from start of trial (time of randomization) through end of trial (12 months)
Milk intake	Process outcome, measured by 24-hour dietary recalls	Change from start of trial (time of randomization) through end of trial (12 months)
Nutrient profile	Added sugars, saturated fat, fiber, calcium; measured by 24-hour dietary recalls	Change from start of trial (time of randomization) through end of trial (12 months)
Food and beverage intake pattern	Vegetables, fruits, legumes, and sugar-sweetened beverages; measured by 24-hour dietary recalls (Ancillary Study) Frequency of consuming between-meal-sugar-containing foods or beverages and consumption of foods (grams) with a high cariogenic potential, measured by 24-hour dietary recalls	Change from start of trial (time of randomization) through end of trial (12 months)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Cara B Ebbeling, PhD, Boston Children's Hospital; Principal Investigator: David S Ludwig, MD, PhD, Boston Children's Hospital

Publications and helpful links

General Publications

• Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605.
• Ebbeling CB. Confusion at the milk cooler: opportunity to bolster the evidence base for preventive nutrition. Am J Clin Nutr. 2020 Feb 1;111(2):240-241. doi: 10.1093/ajcn/nqz319. No abstract available.
• Willett WC, Ludwig DS. Milk and Health. N Engl J Med. 2020 Feb 13;382(7):644-654. doi: 10.1056/NEJMra1903547. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB-P00041990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified IPD on Open Science Framework.
• IPD Sharing Time Frame: The Study Protocol will be posted prior to enrollment of the first study participant. The IPD and Analytic Code for each peer reviewed manuscript from the study will be posted at the time of publication.
• IPD Sharing Access Criteria: The data will be available to any interested party through Open Science Framework.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No