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

NCT05464186 | Recruiting

• 1 other identifier: IRB-P00041990
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases; Obesity; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (33)

• Lean body mass

  Change from start of trial (time of randomization) through end of trial (12 months)

• Percent body fat

  Change from start of trial (time of randomization) through end of trial (12 months)

• Height

  Change from start of trial (time of randomization) through end of trial (12 months)

• Body mass index (BMI)

  Change from start of trial (time of randomization) through end of trial (12 months)

• Leptin

  Change from start of trial (time of randomization) through end of trial (12 months)

Other Outcomes (7)

• Pentadecanoic acid (C15:0)

  Change from start of trial (time of randomization) through end of trial (12 months)

• Heptadecanoic acid (C17:0)

  Change from start of trial (time of randomization) through end of trial (12 months)

• trans Palmitoleic acid (tC16:1ω-7)

  Change from start of trial (time of randomization) through end of trial (12 months)

Study Arms (2)

Whole milk

EXPERIMENTAL

3 cups a day of whole milk for 1 year

Behavioral: Whole milk

Nonfat milk

EXPERIMENTAL

3 cups a day of nonfat milk for 1 year

Behavioral: Nonfat milk

Interventions

Whole milk BEHAVIORAL

Weekly home delivery of whole milk, daily text messages, monthly virtual visits

Whole milk

Nonfat milk BEHAVIORAL

Weekly home delivery of nonfat milk, daily text messages, monthly virtual visits

Nonfat milk

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 9 to 12 years
• BMI ≥75th percentile for sex and age
• Residence in the Greater Boston catchment area

You may not qualify if:

• Aversion to nonfat or whole milk
• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

New Balance Foundation Obesity Prevention Center

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 18779274 BACKGROUND

• 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.

  PMID: 31901161 BACKGROUND

• 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.

  PMID: 32053300 BACKGROUND

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cara B Ebbeling, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna L Lesperance, MA, MPH

CONTACT

617-919-7305; Donna.Lesperance@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, New Balance Foundation Obesity Prevention Center; Associate Professor of Pediatrics

Model Details: Participants will be randomly assigned for 1 year to receive home delivery of: 1) Whole milk, 3 cups a day or 2) Nonfat milk, 3 cups a day.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 19, 2022
• Study Start: December 28, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• Access Criteria: The data will be available to any interested party through Open Science Framework.

Locations

US (1)