625 Participants Needed

Whole Milk vs Low-Fat Milk for Childhood Obesity

LR
Overseen ByLorrene Ritchie, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether participants must stop taking their current medications. However, children on medications that affect growth or daily feeding are excluded from the trial.

Is it safe for children to consume whole milk or low-fat milk?

Research suggests that both whole milk and low-fat milk are generally safe for children. Studies have shown that whole milk might be linked to lower obesity rates in children, while low-fat milk is recommended to reduce fat and calorie intake. No significant safety concerns have been reported for either type of milk in children.12345

How does the treatment of introducing different types of milk compare to other treatments for childhood obesity?

This treatment is unique because it explores the impact of different milk fat contents (whole milk vs. low-fat milk) on childhood obesity, challenging the traditional recommendation of low-fat milk for children over 2 years old. Recent evidence suggests that whole milk might be linked to lower obesity rates, offering a novel approach compared to standard dietary guidelines.12678

What data supports the effectiveness of the treatment Whole Milk vs Low-Fat Milk for Childhood Obesity?

Research suggests that whole milk consumption may be linked to lower obesity rates in children, as studies have found that children who consume more whole milk tend to have lower body fat and healthier weight compared to those who consume low-fat milk.123910

Who Is on the Research Team?

LR

Lorrene Ritchie, PhD

Principal Investigator

Nutrition Policy Institute

Are You a Good Fit for This Trial?

This trial is for parents of children aged 1-2 years who are willing to give their child only whole or 1% milk for a year. They must have internet access, speak and read English, and plan to stay in the SF Bay Area without changing primary caregivers.

Inclusion Criteria

I am willing to give my child only whole or 1% milk for a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to consume either whole milk or 1% milk for one year to evaluate the effect on child adiposity and other health outcomes

12 months
Baseline and 12-month visits

Follow-up

Participants are monitored for changes in adiposity, dietary intake, blood measures, and neurocognitive development

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Child Nutrition Counseling
  • Introduction of Milk Type
Trial Overview The study compares the effects of whole milk (3.5% fat) versus low-fat (1%) milk on preventing obesity in children. It involves random assignment to a milk type and nutrition counseling over one year.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Whole MilkExperimental Treatment2 Interventions
Whole Milk consumption for one year
Group II: 1% MilkExperimental Treatment2 Interventions
1% Milk consumption for one year

Introduction of Milk Type is already approved in United States for the following indications:

🇺🇸
Approved in United States as Whole Cow's Milk for:
  • Support for rapid early growth and brain development in children aged 1-2 years
🇺🇸
Approved in United States as Low-Fat Milk / 1% Milk for:
  • Reduction of saturated fat and calorie intake in children aged 2 years and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

Published Research Related to This Trial

In a study of 145 Latino preschoolers, higher consumption of milk fat was linked to lower odds of severe obesity, suggesting that whole fat dairy may be protective against obesity in this population.
Severely obese children consumed less milk fat (5.3 g) compared to their non-severely obese peers (8.9 g), indicating that promoting lower fat milk may not be beneficial for preventing obesity in young children.
Full fat milk consumption protects against severe childhood obesity in Latinos.Beck, AL., Heyman, M., Chao, C., et al.[2023]
The Cow's Milk Fat Obesity pRevention Trial will involve 534 children aged 2 to 4-5 years to compare the effects of whole milk versus reduced fat milk on body fat and overall health over 24 months.
This study aims to provide evidence on whether whole milk can help minimize excess body fat and improve nutrition in children, potentially influencing future dietary guidelines to combat childhood obesity.
Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity.Vanderhout, SM., Aglipay, M., Birken, C., et al.[2023]
A comprehensive review of 94 studies found that milk and dairy products are generally not associated with obesity in children, and in some cases, they may even be inversely related to body fatness.
The review suggests that there are no significant differences in the effects of various types of milk or dairy products on obesity, and it concludes that there is little evidence to justify limiting dairy consumption in children due to concerns about weight gain.
A critical review of the role of milk and other dairy products in the development of obesity in children and adolescents.Dougkas, A., Barr, S., Reddy, S., et al.[2020]

Citations

Full fat milk consumption protects against severe childhood obesity in Latinos. [2023]
Cow's Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cow's milk fat on child adiposity. [2023]
A critical review of the role of milk and other dairy products in the development of obesity in children and adolescents. [2020]
Prospective association between milk intake and adiposity in preschool-aged children. [2022]
Associations between Dairy Intake, Body Composition, and Cardiometabolic Risk Factors in Spanish Schoolchildren: The Cuenca Study. [2020]
Predictors of dietary milk fat intake by preschool children. [2021]
Effects of switching from whole to low-fat/fat-free milk in public schools - New York city, 2004-2009. [2010]
Feeding low-fat milk during infancy. [2015]
Whole milk compared with reduced-fat milk and childhood overweight: a systematic review and meta-analysis. [2023]
Cow's milk fat and child adiposity: a prospective cohort study. [2022]
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