Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study
NCT ID: NCT07309536
Last Updated: 2026-01-02
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-02-01
2027-11-01
Brief Summary
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In this study, toddlers will be randomly assigned to a 3-week MED diet or their usual diet. Families in the MED diet group will receive free meal boxes for the 3 weeks, plus guidance from a nutrition researcher through a structured education program. The standard diet group will continue their regular diet with general nutrition advice. Researchers will collect dietary information, body composition assessments, and stool samples to measure gut microbiome composition and metabolites.
This first study of a controlled diet intervention in toddlers, combining behavioral support, high-quality food provision, and advanced gut microbiome analysis, will help understand how early diet shapes lifelong eating habits and health, guiding public health strategies and precision nutrition approaches to prevent chronic disease from early life.
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Detailed Description
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The aims of this study are to determine the effects of a (i) MED diet food-provision intervention on dietary inflammation, the gut microbiome and metabolites, and body composition of toddlers aged 2-3 years at 3 weeks and (ii) comprehensive, tailored nutrition education program, with or without food provision, in promoting adherence to the prescribed diets at 3 weeks and 3 months post-baseline.
This parallel randomized controlled trial at the University of New Brunswick will randomized parent-toddler dyads to either a 3-week MED diet or a Standard diet. Families in the MED diet group will receive free food provision and a tailored, theory-driven parental nutrition program. They will be provided with packaged food boxes including three meals (breakfast/lunch/dinner) and two snacks for each day of the week. Meals will be developed and prepared by a registered dietitian in UNB's metabolic kitchen under sterile conditions and delivered to parents in coolers. Families in the Standard diet group will continue to consume their regular diet and receive general nutrition education. Both groups will be initially screened using the KIDMED 2.0 to ensure they do not already adopt a MED diet. The nutrition education programs will be delivered over a 3-month period from baseline.
The primary outcome is the between-group difference in Children's Dietary Inflammatory Index scores at 3 weeks, diet adherence, and program satisfaction. Secondary outcomes include microbial diversity, taxa, metabolite profiles, body composition, blood pressure, and additional feeding metrics. Assessments will occur at baseline, 3 weeks, and 3 months. Stool samples will be analyzed using shallow shotgun metagenomics and metabolomics to assess microbial taxa, SCFAs, and other metabolites. Statistical analyses, conducted in R, will include t-tests, PERMANOVA, and mediation models.
The toddler years are a pivotal time for shaping lifelong eating habits and health outcomes, persisting into adolescence and adulthood. This is the first trial to test a controlled dietary intervention in toddlers, integrating behavioural theory and patient-oriented research. It will bring together a multifaceted team, combining expertise in nutrition and dietetics with cutting-edge knowledge in genomics for gut microbiome analysis. Findings will inform public health strategies and advance precision nutrition to reduce chronic disease risk from early life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Mediterranean Diet Intervention
Toddlers in this group will follow a Mediterranean-style diet for nine weeks. Families will receive Mediterranean diet foods for three weeks and take part in nine weekly sessions (one overview and eight follow-up sessions) focused on preparing toddler-appropriate Mediterranean meals. The sessions are designed to support consistency in feeding, track progress, and provide guidance on diet adherence. Measurements of toddler height, weight, body composition (BOD POD), stool samples, and questionnaires will be collected at baseline, 3 weeks, and 3 months post-baseline.
Mediterranean Diet Nutrition Program
A nine session nutrition and feeding program designed to assess how a Mediterranean-style diet influences toddler gut health, body composition, and inflammation. Toddlers will receive Mediterranean-style foods for the first three weeks, followed by continued guidance through bi-weekly educational sessions focused on meal preparation, food variety, and adherence. Specifically sessions will cover key topics such as toddler nutrient needs, budget-friendly meal planning, picky eating, family mealtime strategies, and mindful eating. The program emphasizes incorporating fruits, vegetables, legumes, whole grains, and healthy fats into toddler meals, reducing ultra-processed foods, and promoting balanced feeding during early childhood.
Standard Diet
Toddlers in this group will continue their usual diets for nine weeks while families participate in nine weekly general nutrition education sessions. Measurements of toddler height, weight, body composition (BODPOD), stool samples, and questionnaires will occur at the same time points as the intervention group. Families in this group will receive a $100 honorarium.
Standard Diet Education Program
An eight session general toddler nutrition education program designed to reflect typical dietary patterns in Canadian families. Families receive sessions on topics such as feeding styles, cultural foods and feeding practices, understanding nutrition labels, food safety, choking hazards and prevention, healthy recipes, myths and misinformation, and meal structure and routines. No study foods are provided. Toddlers maintain their usual diets throughout the study while completing the same measurements as those in the intervention group.
Interventions
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Mediterranean Diet Nutrition Program
A nine session nutrition and feeding program designed to assess how a Mediterranean-style diet influences toddler gut health, body composition, and inflammation. Toddlers will receive Mediterranean-style foods for the first three weeks, followed by continued guidance through bi-weekly educational sessions focused on meal preparation, food variety, and adherence. Specifically sessions will cover key topics such as toddler nutrient needs, budget-friendly meal planning, picky eating, family mealtime strategies, and mindful eating. The program emphasizes incorporating fruits, vegetables, legumes, whole grains, and healthy fats into toddler meals, reducing ultra-processed foods, and promoting balanced feeding during early childhood.
Standard Diet Education Program
An eight session general toddler nutrition education program designed to reflect typical dietary patterns in Canadian families. Families receive sessions on topics such as feeding styles, cultural foods and feeding practices, understanding nutrition labels, food safety, choking hazards and prevention, healthy recipes, myths and misinformation, and meal structure and routines. No study foods are provided. Toddlers maintain their usual diets throughout the study while completing the same measurements as those in the intervention group.
Eligibility Criteria
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Inclusion Criteria
* Carried a singleton pregnancy.
* Delivered at term (≥37 weeks gestation).
* Delivered vaginally or by cesarean section.
* Infant was born with a birth weight between 2,500 g and 4,500 g.
* Toddler is between 24 and 36 months of age at enrollment.
* Parent is able to communicate in English.
* Parent is willing to adhere to the Mediterranean diet for their toddler for 3 weeks.
* Parent is willing to participate in a nutrition education program for 3 months.
* Parent is willing to complete all measurements and provide a stool sample from their toddler.
Exclusion Criteria
* Toddler is at high risk for food allergies (e.g., strong family history of multiple food allergies common to the Mediterranean diet).
* Toddler is already following a Mediterranean diet.
* Toddler has had recent or active consumption of antibiotics, probiotics, or prebiotic drops.
* Toddler has an active acute illness, such as fever, diarrhea, or constipation.
* Toddler was born with a congenital illness or malformation that could affect diet, inflammation, gut health, or body composition.
* Toddler is currently breastfeeding, formula-feeding, or combination feeding.
24 Months
36 Months
ALL
Yes
Sponsors
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University of New Brunswick
OTHER
Responsible Party
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Maryam Kebbe
Associate Professor
Principal Investigators
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Dr. Maryam Kebbe, PhD, CLC
Role: PRINCIPAL_INVESTIGATOR
University of New Brunswick
Locations
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University of New Brunswick
Fredericton, New Brunswick, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
Access external resources that provide additional context or updates about the study.
Kebbe M. Nutribiomes Youtube Channel.
CMAJ. Patient-Oriented Research Collection.
World Health Organization. (2018). Noncommunicable diseases fact sheet.
Statistics Canada. (2020). Leading causes of death, total population, by age group. Accessed August 20, 2024.
Other Identifiers
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REB 2025-146
Identifier Type: -
Identifier Source: org_study_id
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