Clinical trial Recruiting at 1 site Interventional Ages 23 Months to 48 Months

Impact of Whole Versus Low-fat Milk on Child Health

Official title: Milk Type in Toddlers (Milk-TOT) Study: Impact of Whole Versus Low-fat Milk on Child Adiposity, Health and Development

Run by University of California, Davis · NCT06230510 · Data updated 2026-11-12

This study tests whether whole milk or low-fat milk is better for the health and weight of toddlers aged 2 to 3 years.

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Quick facts

Study typeInterventional
Ages23 Months to 48 Months
SexAll
Enrollment625 (estimated)
SponsorUniversity of California, Davis
Academic / other
Locations1 site (Oakland, California)
StatusRecruiting
StartedAugust 15, 2024
Main results expectedDecember 31, 2027
Study endsJune 30, 2028
Registry record updatedMay 18, 2026
Trial IDNCT06230510 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are parents of toddlers aged 2 to 3 years who are willing to participate in the milk intervention and meet the study's eligibility criteria.

Probably not a fit

Patients with specific medical conditions affecting growth or feeding, or those outside the age range of 23 to 48 months, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of whole cow's milk compared to 1% low-fat milk on child obesity and health outcomes in toddlers aged 2 to 3 years. It aims to determine how different milk fat types influence adiposity, measured by waist-to-height ratio and other metrics. The study will recruit 625 parents and randomly assign their toddlers to either milk group for one year, with a focus on understanding the implications of milk fat on early childhood growth and development.

Why it matters

Potential benefit: If successful, this study could provide evidence to guide dietary recommendations for preventing obesity in young children.

How similar studies have gone: While few rigorous trials have focused on this specific question, existing observational studies suggest a complex relationship between milk fat consumption and child adiposity, indicating that this approach may yield novel insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Parents of children: 1) willing to be randomized to provide either only whole or 1% milk to their child for 1 year, 2) access to a smart phone and a tablet, laptop or computer with internet and email at home, 3) ability to speak and read English or Spanish for the purposes of receiving study communications and completing surveys and dietary assessments (to avoid needing to translate all study materials and have research staff fluent in other languages due to budget limits), 4) not planning to move outside of the San Francisco Bay Area or discontinue being child's primary caregiver for the next year (e.g., foster care, parent separation).

Exclusion Criteria:

Children: 1) \<23 months or \>48 months old at recruitment; 2) condition or medication that affects growth or daily feeding, or cardiometabolic health such as hypopituitarism, growth hormone deficiency, inborn error of metabolism, syndromic obesity, familial hypercholesterolemia, 3) weight-for-length or height below the 2nd percentile, 4) lactose intolerance, milk allergy or other dietary restrictions (e.g., vegan) that impact ability to consume dairy or otherwise limit dietary intake, 5) resides in more than one household (e.g., shared care by separated parents), and 6) not covered by public or private medical insurance (may reduce well-child doctor visits). If two eligible children are in a household, one will be randomly selected to participate.

Where it's running

  • Nutrition Policy Institute, University of California Agriculture and Natural Resources
    Oakland, California, United States
    Recruiting

Study contacts

  • Principal investigator: Lorrene Ritchie, PhD — Nutrition Policy Institute
  • Study coordinator: Lorrene Ritchie, PhD
  • Email: lritchie@ucanr.edu
  • Phone: (510) 987-0523

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.