Mediterranean Diet for Toddler Health

(MUNCHIES Trial)

DM
Overseen ByDr. Maryam Kebbe, PhD, CLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if following a Mediterranean diet for three weeks can improve gut health, reduce dietary inflammation, and positively impact body composition in toddlers. Researchers seek to understand whether early dietary changes can shape better long-term eating habits and health outcomes. Toddlers will either follow a Mediterranean diet with meal boxes and guidance (Mediterranean Diet Nutrition Program) or continue their usual diet with general nutrition advice (Standard Diet Education Program). Ideal candidates are toddlers aged 2-3 whose parents can commit to the diet and educational program, without dietary restrictions or recent antibiotic use. As an unphased trial, this study provides a unique opportunity for parents to contribute to understanding the potential long-term health benefits of early dietary interventions.

Do I have to stop my toddler's current medications for the trial?

The trial does not specify if you need to stop your toddler's current medications, but it does exclude toddlers who have recently taken antibiotics, probiotics, or prebiotic drops.

What prior data suggests that the Mediterranean Diet Nutrition Program is safe for toddlers?

Research shows that the Mediterranean diet is generally safe for children. Studies have found that children on this diet often experience better health, including less inflammation and improved gut health.

While few studies focus specifically on toddlers, the Mediterranean diet's emphasis on fruits, vegetables, whole grains, and healthy fats is widely regarded as healthy. This study does not test a new drug or chemical; it aims to understand the effects of a well-known diet.

Since toddlers will consume regular foods, there are no major safety concerns. However, parents should ensure their children are not allergic to any foods in the diet. Overall, the Mediterranean diet is well-tolerated and linked to various health benefits in children.12345

Why are researchers excited about this trial?

Researchers are excited about the Mediterranean Diet Nutrition Program for toddlers because it offers a holistic and culturally rich approach to nutrition that could foster healthier eating habits from a young age. Unlike typical dietary guidelines that focus on basic nutritional needs, this program emphasizes a variety of nutrient-rich foods like fruits, vegetables, whole grains, and healthy fats, which are staples of the Mediterranean diet. Additionally, the program includes hands-on meal preparation sessions for families, which can strengthen adherence and provide practical skills for maintaining a balanced diet. This approach not only aims to improve immediate health markers like weight and body composition but also instills lifelong healthy eating behaviors.

What evidence suggests that this trial's treatments could be effective for toddler health?

This trial will compare the effects of a Mediterranean Diet Nutrition Program with a Standard Diet Education Program for toddlers. Research has shown that the Mediterranean diet benefits children's health. Studies have found that it helps prevent obesity and heart problems and lowers the risk of diabetes. This diet encourages eating more fruits and vegetables, supporting healthy growth and development in kids. Additionally, when families follow this diet, children are more likely to maintain a healthy weight. Overall, the Mediterranean diet promotes better eating habits from a young age.36789

Who Is on the Research Team?

DM

Dr. Maryam Kebbe, PhD, CLC

Principal Investigator

University of New Brunswick

Are You a Good Fit for This Trial?

The MUNCHIES study is for toddlers aged 2-3 whose parents are over 19, can communicate in English, and agree to follow a Mediterranean diet for their child. Eligible toddlers must have been born full-term with normal birth weight and can be delivered naturally or via C-section. Parents should commit to a nutrition program and provide necessary measurements and samples.

Inclusion Criteria

I am willing to provide my toddler's measurements and a stool sample.
I am a parent and I am 19 years old or older.
My child is between 2 and 3 years old.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Toddlers are assigned to either a Mediterranean diet or their usual diet for 3 weeks. The MED diet group receives free meal boxes and nutrition education.

3 weeks
Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for dietary adherence, gut microbiome changes, and body composition at 3 weeks and 3 months post-baseline.

3 months
Assessments at 3 weeks and 3 months

Nutrition Education Program

Families participate in a tailored nutrition education program to promote adherence to the prescribed diets.

3 months
Nine weekly sessions

What Are the Treatments Tested in This Trial?

Interventions

  • Mediterranean Diet Nutrition Program
  • Standard Diet Education Program

Trial Overview

This trial tests if a Mediterranean Diet improves toddler health compared to usual diets. Toddlers will either receive the special diet with meal boxes and education for parents or continue regular eating habits with basic nutrition advice. The impact on gut health, inflammation, body composition, and long-term dietary patterns will be studied.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mediterranean Diet InterventionExperimental Treatment1 Intervention
Group II: Standard DietActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of New Brunswick

Lead Sponsor

Trials
25
Recruited
2,700+

Citations

A New Mediterranean Lifestyle Pyramid for Children and ...

Adopting healthy dietary patterns can help curb childhood obesity, a worrisome epidemic problem at present. In the era of personalized nutrition, dietary ...

Mediterranean Diet in Developmental Age: A Narrative ...

Numerous studies in recent decades have shown that Mediterranean diet (MD) can reduce the risk of developing obesity in pediatric patients.

Effectiveness of an Intervention Programme on Adherence to ...

In children, it has positive effects in the prevention of obesity and cardiovascular diseases, as well as in the prevention of diabetes. We ...

Is the Mediterranean diet healthy for kids?

"It encourages positive changes, like eating more fruits and vegetables. This approach to eating can help children grow and meet their ...

The Role of Parental Adherence to the Mediterranean Diet ...

For instance, promoting adherence to the Mediterranean diet among families with school-aged children can contribute to children's healthier weight status.

Mediterranean Diet Uptake and Nutrition on Child Health ...

This study will test whether a MED diet can improve dietary inflammation, gut health, and body composition in toddlers and whether a tailored ...

Childhood Mediterranean Diet Compliance Is Associated with ...

This study reported that only 4.3% of the children attained an optimal KIDMED score. Children with higher KIDMED scores reported healthier ...

The Diet of Preschool Children in the Mediterranean ...

This systematic review discusses data on the dietary intake of preschool children living in the Mediterranean countries of the European Union.

Determinants of the adherence to Mediterranean diet

The aim of this study was to investigate the associations between adherence to the Mediterranean diet, lifestyle, socioeconomic status, BMI (kg/m 2 ), and age ...