Whole vs Nonfat Milk for Childhood Obesity

Overseen By Donna L Lesperance, MA, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must not be taking: Chronic medications

Disqualifiers: Major illness, Eating disorder, Milk allergy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 52 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how drinking whole milk versus nonfat milk affects children's health and diet. Researchers aim to determine if milk type influences body fat, heart disease risk factors, and overall diet quality. Participants will consume either whole or nonfat milk daily for a year. Children aged 9-12 with a BMI in the 75th percentile or higher, living near Boston, and without major health issues or milk allergies, are suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of milk type on children's health.

Will I have to stop taking my current medications?

The trial requires that participants do not use any medication or dietary supplement that could affect the study outcomes, so you may need to stop taking certain medications.

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

Research has shown that whole milk might help children manage their weight. One review found that kids who drank whole milk were 40% less likely to be overweight or obese compared to those who drank low-fat milk, suggesting that whole milk is generally well-tolerated by children.

For nonfat milk, results are mixed. Switching from whole to nonfat milk in schools reduced calorie and fat intake, potentially aiding weight management. However, international guidelines recommending low-fat milk have not consistently shown a lower risk of obesity in children. This indicates that both whole and nonfat milk are generally safe, but they might affect weight differently.

Overall, drinking either whole or nonfat milk appears safe for children, with no major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using different types of milk in the fight against childhood obesity because they offer a simple, dietary-based approach that could be easily adopted by families. Unlike typical treatments that might involve medications or structured exercise programs, this approach focuses on a basic dietary swap: choosing either whole milk or nonfat milk. Whole milk contains more calories and fats, which could influence satiety and energy balance differently compared to nonfat milk. By understanding how these two types of milk impact weight and health, researchers hope to uncover an effective, everyday strategy for managing 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 nonfat milk on childhood obesity. Research has shown that drinking whole milk might be linked to a lower chance of being overweight in children. One study found that kids who drank whole milk had a much lower risk of being overweight compared to those who drank reduced-fat milk. Another study showed that whole milk does not negatively affect body weight or composition in children and teens.

For nonfat milk, evidence suggests that drinking milk, whether full-fat or nonfat, doesn't significantly prevent obesity in young children. Studies have also shown that switching from whole to nonfat milk could help reduce fat intake, which might aid in weight management. Overall, both whole and nonfat milk have their own benefits, but neither is clearly superior in preventing obesity. Participants in this trial will be assigned to either the whole milk or nonfat milk group to further explore these findings. ^{5 6 7 8 9}

Who Is on the Research Team?

David Ludwig, MD PhD

Principal Investigator

Boston Children's Hospital

Cara B Ebbeling, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 9 to 12 with a BMI in the top 15% for their age and sex, living near Boston. It's not for those planning to move or be away long-term, with certain abnormal lab tests, major weight changes recently, on special diets, if someone at home is also in the study, or with milk allergies or serious health issues.

Inclusion Criteria

Residence in the Greater Boston catchment area

I am between 9 and 12 years old.

My BMI is in the top 25% for my age and sex.

Exclusion Criteria

Aversion to nonfat or whole milk

I have a major illness, eating disorder, or milk allergy (but not lactose intolerance).

Plans to move away from the Greater Boston catchment area during the study period

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 nonfat milk, 3 cups per day, for 1 year

52 weeks

3 visits (baseline, 6 months, 12 months)

Follow-up

Participants are monitored for changes in body composition and cardiometabolic risk factors after the treatment period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nonfat Milk
• Whole Milk

Trial Overview The study compares the effects of drinking whole milk versus nonfat milk on kids' body fat and muscle composition. It also looks at how these milks affect risks for heart disease, obesity-related conditions like diabetes, and overall diet quality.

How Is the Trial Designed?

Group I: Whole milk Experimental Treatment 1 Intervention

3 cups a day of whole milk for 1 year

Group II: Nonfat milk Experimental Treatment 1 Intervention

3 cups a day of nonfat milk for 1 year

Nonfat Milk is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nonfat Milk for:

• General nutrition
• Cardiovascular health

Approved in European Union as Skim Milk for:

• General nutrition
• Weight management

Approved in Canada as Fat-Free Milk for:

• General nutrition
• Cardiovascular health

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

In a study of 342 non-obese children aged 4 to 10, higher calcium intake was linked to lower body mass index (BMI) and reduced body fat in non-hypercholesterolemic children aged 7 to 10 over a year.

Dairy intake also showed an inverse relationship with obesity measures at baseline in the same age group, suggesting that older children without metabolic syndrome risk may benefit from increased calcium and dairy consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium and dairy intake and measures of obesity in hyper- and normocholesterolemic children. Dixon, LB., Pellizzon, MA., Jawad, AF., et al.[2013]

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 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]

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]

A systematic review of 29 studies involving children aged 2 to 18 found that whole-fat dairy products are not linked to increased weight gain or adiposity, challenging current dietary guidelines that recommend reduced-fat dairy for children.

Most evidence suggests that whole-fat dairy does not raise cardiometabolic disease risk in children, indicating a need for more high-quality randomized controlled trials to better understand the effects of dairy fat on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Fat or Reduced-Fat Dairy Product Intake, Adiposity, and Cardiometabolic Health in Children: A Systematic Review. O'Sullivan, TA., Schmidt, KA., Kratz, M.[2023]

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]

In a study of 2455 children from the Avon Longitudinal Study, high total dairy consumption at age 10 was not linked to an increased risk of excess body fat or overweight by age 13.

Children consuming higher amounts of full-fat dairy showed a reduced risk of excess body fat and smaller gains in BMI compared to those consuming less, suggesting potential benefits of full-fat dairy in managing childhood adiposity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dairy intakes at age 10 years do not adversely affect risk of excess adiposity at 13 years. Bigornia, SJ., LaValley, MP., Moore, LL., et al.[2023]

In a study of 884 children aged 7.5 years, higher frequency of milk consumption was significantly associated with lower BMI z-scores, suggesting that drinking milk may help in managing body weight in children.

This is the first study to report a significant inverse relationship between milk consumption and body mass in children, highlighting the need for further research on dietary calcium's role in obesity prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inverse association between body mass and frequency of milk consumption in children. Barba, G., Troiano, E., Russo, P., et al.[2019]

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]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6536827/

A critical review of the role of milk and other dairy products ... Results showed that the decrease in percentage body fat was less in overweight/obese children who consumed flavoured milk (17 %) than non-consumers of flavoured ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05464186?term=SKIM%20MILK&viewType=Table&rank=5

Effects of Whole vs. Nonfat Milk Consumption on Body ... This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1499404614007556

Potential Population-Level Nutritional Impact of Replacing ... This study used data from NHANES to quantitatively examine the potential nutritional and economic impact of substituting low-fat and skim milk for whole, ...

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

Effects of Switching from Whole to Low-Fat/Fat-Free Milk in ... DOE determined that reducing consumption of whole milk and increasing consumption of fat-free or low-fat milk could help decrease students' fat ...

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

Whole milk compared with reduced-fat milk and childhood ... Among children who consumed whole (3.25% fat) compared with reduced-fat (0.1–2%) milk, the OR of overweight or obesity was 0.61 (95% CI: 0.52, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31851302/

Whole milk compared with reduced-fat milk and childhood ... International guidelines that recommend reduced-fat milk for children might not lower the risk of childhood obesity.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322003180

Whole-Fat or Reduced-Fat Dairy Product Intake, Adiposity, ... Usual consumption of whole-fat milk was associated with lower odds of overweight and obesity compared with those who usually consumed reduced-fat milk** across ...

9. dairynutrition.ca dairynutrition.ca/en/nutrition-and-health/weight-and-dairy/healthy-weight-results-studies-children-and-adolescents

Milk Products Aid Healthy Weight in Kids Despite some variability across studies, children who consumed whole-fat milk had a 39% decreased risk of being overweight or obese compared to ...