Whole Milk vs Low-Fat Milk for Childhood Obesity

Overseen By Lorrene Ritchie, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Growth conditions, Metabolic disorders, Milk allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 months

625 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether whole milk or 1% milk is more effective in preventing obesity in young children. Researchers will compare the effects of whole milk and low-fat 1% milk on children's body fat over a year. Parents who provide milk to their children and have access to a smartphone and internet at home may be suitable participants. Based in the San Francisco Bay Area, the trial requires parents to commit to providing a specific type of milk to their child for one year. As an unphased trial, this study offers a unique opportunity for parents to contribute to important research on childhood nutrition and obesity prevention.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that whole milk is usually well-tolerated by children. One study found that kids who drank whole milk, which contains about 3.25% fat, were less likely to be overweight than those who drank low-fat milk. Another study found that drinking higher-fat milk in early childhood did not lead to increased body fat or heart problems later on.

Health guidelines suggest 1% milk for kids over 2 years old to help reduce the risk of obesity. The American Academy of Pediatrics and the American Heart Association also recommend this type of milk as safe.

Both whole milk and 1% milk have been consumed by many children without major safety concerns. In general, both types are safe for kids to drink. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about studying the effects of whole milk and 1% milk on childhood obesity because they aim to explore how different types of milk might influence weight management in children. Unlike other treatments that often involve significant dietary changes or medication, this approach examines how a simple switch in milk type could impact obesity. Whole milk and 1% milk are commonplace dietary staples, making this intervention potentially easy to adopt and maintain in everyday life. By focusing on milk consumption, researchers hope to uncover a straightforward and sustainable way to address childhood obesity.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

This trial will compare the effects of whole milk and 1% milk on childhood obesity. Past studies have shown that children who drank whole milk had a much lower chance of being overweight or obese compared to those who drank low-fat milk. Specifically, one study found that children who drank whole milk were 39% less likely to be overweight or obese. Another study demonstrated that drinking milk with more fat was linked to a lower chance of severe obesity in Latino preschoolers. However, some research suggests that drinking 1% milk might not help prevent obesity in children. In fact, children who drank 1% milk were more likely to become overweight or obese as they got older. Overall, current evidence suggests that whole milk may be better for managing children's weight than 1% milk. ^{2 4 6 7 8}

Who Is on the Research Team?

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?

Group I: Whole Milk Experimental Treatment 2 Interventions

Whole Milk consumption for one year

Group II: 1% Milk Experimental Treatment 2 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

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

A systematic review of 28 studies involving 20,897 children found that higher consumption of whole cow-milk (3.25% fat) is associated with lower rates of overweight and obesity compared to reduced-fat milk (0.1-2% fat).

Current guidelines recommending reduced-fat milk for children may not effectively reduce the risk of childhood obesity, suggesting a need for randomized trials to identify the optimal cow-milk fat content for minimizing adiposity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole milk compared with reduced-fat milk and childhood overweight: a systematic review and meta-analysis. Vanderhout, SM., Aglipay, M., Torabi, N., et al.[2023]

The NYC Department of Education successfully removed whole milk from public schools, leading to a 1.3% increase in milk purchases per student by 2009 compared to 2004, indicating that students continued to consume milk despite the change.

This policy change resulted in significant reductions in calorie and fat intake, with students consuming approximately 5,960 fewer calories and 619 fewer grams of fat in 2009 than in 2004, demonstrating the effectiveness of the intervention in promoting healthier dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of switching from whole to low-fat/fat-free milk in public schools - New York city, 2004-2009. [2010]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 significant number of infants in the U.S. were fed low-fat milk, despite recommendations against it, with 32% of 12-month-olds consuming it in 1985, often due to misconceptions about its health benefits.

Infants consuming low-fat milk had similar nutrient intakes to those on whole cow's milk, but both groups exceeded safe levels for sodium, potassium, and chloride, while also falling short on iron intake, highlighting potential dietary risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding low-fat milk during infancy. Ryan, AS., Martinez, GA., Krieger, FW.[2015]

In a study of 852 preschool-aged children, higher intake of whole milk at age 2 was linked to a slightly lower BMI z score at age 3, but this effect was not significant for children with a normal BMI at age 2.

Overall, neither the amount of dairy consumed nor the type of milk (whole vs. reduced-fat) at age 2 was associated with a reduced risk of becoming overweight by age 3, suggesting that dairy intake alone may not be effective in preventing early childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective association between milk intake and adiposity in preschool-aged children. Huh, SY., Rifas-Shiman, SL., Rich-Edwards, JW., et al.[2022]

In a study of 7467 children aged 9 months to 8 years, higher intake of whole cow's milk fat was associated with lower body mass index z-scores (zBMI), suggesting that whole milk may help in maintaining a healthier weight.

Children consuming whole milk had significantly lower odds of being overweight (16% lower) and obese (18% lower) compared to those consuming reduced fat milk, indicating that current guidelines favoring reduced fat milk may not effectively prevent obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cow's milk fat and child adiposity: a prospective cohort study. Vanderhout, SM., Keown-Stoneman, CDG., Birken, CS., et al.[2022]

A study of 1,938 children aged 1 to 5 found that 75% consumed whole milk, with factors like younger age and parental beliefs about health influencing this choice.

To encourage lower fat milk consumption, targeted family-based strategies are needed, such as taste testing and addressing cultural beliefs about milk health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of dietary milk fat intake by preschool children. Dennison, BA., Erb, TA., Jenkins, PL.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full fat milk consumption protects against severe childhood obesity in Latinos. Beck, AL., Heyman, M., Chao, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 1088 Spanish schoolchildren aged 8 to 11, those who consumed more whole-fat milk had lower body mass index (BMI) and fat mass, suggesting that full-fat dairy may not contribute to obesity as previously thought.

Children with healthier blood lipid profiles, including normal triglycerides and high-density lipoprotein (HDL) cholesterol, also preferred whole-fat milk over reduced-fat options, indicating potential cardiovascular benefits associated with full-fat dairy consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between Dairy Intake, Body Composition, and Cardiometabolic Risk Factors in Spanish Schoolchildren: The Cuenca Study. Lahoz-García, N., Milla-Tobarra, M., García-Hermoso, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7228521/

Cow's Milk Fat Obesity pRevention Trial (CoMFORT) Observational evidence supports that children who consume whole milk have a lower risk of overweight or obesity relative to children who ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06230510

Milk-Tot Study: Impact of Whole Versus Low-fat ... This randomized controlled trial will evaluate the effect of consumption of whole versus 1% milk on child adiposity and other health and developmental outcomes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3229928/

Prospective association between milk intake and adiposity ... Our findings suggest that a higher intake of milk, whether full- or low-fat, is unlikely to prevent the development of obesity among preschool-age children.

4. childrensmercy.org childrensmercy.org/contentassets/ba29046f39334da9bc6486e29b1f470a/low-fat-dairy-intake-and-bmi-013118.pdf

Critically Appraised Topic: Low Fat Dairy Intake and BMI In longitudinal analysis, children drinking 1%/skim milk at both 2 and 4 years were more likely to become overweight/obese between these time points (adjusted ...

5. cdc.gov cdc.gov/mmwr/preview/mmwrhtml/mm5903a2.htm

Effects of Switching from Whole to Low-Fat/Fat-Free Milk in ... The switch to lower-fat milk likely has improved the overall nutritional environment of NYC public schoolchildren. The switch also might promote ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6997094/

Whole milk compared with reduced-fat milk and childhood ... Children aged >2 y are recommended to consume reduced-fat (0.1–2%) cow-milk to lower the risk of obesity. Objectives. To evaluate the relation ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2211335517301171

Full fat milk consumption protects against severe childhood ... While the AAP and the AHA both recommend that children drink 1% or skim milk, we document that higher milk fat consumption is associated with a lower risk of ...

8. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(22)00060-0/fulltext

Association of cow's milk intake in early childhood with ... In conclusion, in this prospective cohort study, early childhood consumption of whole or 2% milk, compared with 1% or skim milk, was associated with lower odds ...