MedTrace Logo

Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health

NCT06230510 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 625

Last updated 2026-05-18

No results posted yet for this study

Summary

In the U.S. it is recommended that children consume whole cow's milk (3.5% fat) from ages 1 to 2 years to support rapid early growth and brain development, and then at age 2 years transition to low-fat (1%) or non-fat milk to reduce saturated fat and calorie intake. To date, few studies have examined the optimal milk type for children to prevent obesity. This randomized controlled trial will evaluate the effect of consumption of whole versus 1% milk on child adiposity.

Conditions

Interventions

BEHAVIORAL

Introduction of Milk Type

Beginning at approximately age 2, milk (equivalent to 2 cups/day) will be provided at no cost to the family for one year.

BEHAVIORAL

Child Nutrition Counseling

Parent/caregivers will receive quarterly phone-based counseling by a Registered Dietitian (RD) on how to introduce the toddler to the assigned milk and the importance of continuing to drink the assigned milk for the one year.

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Lorrene Ritchie, PhD · Nutrition Policy Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06230510 on ClinicalTrials.gov