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NCT06230510Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 18 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
625 (estimated)
First submitted
11 Dec 2023
Start date
15 Aug 2024
Primary completion date
31 Dec 2027
Lead sponsor
University of California, Davis
Diseases
Obesity
NCT number
NCT06230510

What you commit to

  • Study type: Interventional
  • Planned participants: 625
  • From 15 Aug 2024 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 23 months to 48 months · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nutrition Policy Institute, University of California Agriculture and Natural Resources
Coordinator of this site? Confirm its status
OaklandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.