Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230510
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-12-11
Brief Title:
Milk-Tot Study Impact of Whole Versus Low-fat Milk on Child Health
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Milk Type in Toddlers Milk-TOT Study Impact of Whole Versus Low-fat Milk on Child Adiposity Health and Development
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the US it is recommended that children consume whole cows milk 35 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
Detailed Description:
The prevalence of child obesity in the US has tripled since the 1970s and excess weight gain - even in young children - is a precursor to adult obesity and associated co-morbidities In the US it is recommended that children consume whole cows milk 35 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 However surprisingly few rigorous trials to support recommendations on optimal milk type have been conducted and existing observational studies paradoxically suggest that lower fat milk consumption is associated with increased adiposity in children The effects of the types of fat found in milk on cardiometabolic disease risk have also been questioned This randomized controlled trial will evaluate the effect of consumption of whole versus 1 milk on child adiposity and other health and developmental outcomes beginning after toddlers have successfully transitioned from breastmilk andor formula to cows milk at 2 years of age Investigators will recruit 625 parents of toddlers and randomly assign 625 toddlers to either whole or 1 milk groups for 1 year with estimated final sample size of 500 Our primary aim is to determine how milk fat type whole versus 1 consumed from age 2 to 3 years affects change in adiposity as measured by waist-to-height ratio primary outcome body mass index tri-ponderal mass index and waist circumference Secondary aims are to evaluate how milk type consumed from age 2 to 3 years affects changes in milk total and saturated fat added sugars and total energy intake and overall diet quality as well as blood lipids and vitamin D status and neurocognitive development Results from the Milk-TOT Study can help pediatric health care providers give evidence-based dietary recommendations to improve child weight and health and can inform the types of milk provided to participants in the federal nutrition programs which collectively provide milk to over half of all young children in the US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None