Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study

NCT07309536 | Not Yet Recruiting

• 1 other identifier: REB 2025-146
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Toddlerhood (ages 2-3) is a critical window when the gut microbiome is still developing and eating habits are being established. Yet, many Canadian toddlers eat diets high in sugar and salt, which may affect long-term health. This study will test whether a MED diet can improve dietary inflammation, gut health, and body composition in toddlers and whether a tailored nutrition education program for parents can help families maintain healthy eating patterns. 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.

Conditions

Gut Microbiome; Body Composition; Adherence; Metabolites; Inflammation

Keywords

Dietary patterns; Gastrointestinal microbiome; Body composition; Inflammation

Outcome Measures

Primary Outcomes (3)

• Mediterranean Diet Adherence

  Adherence to the Mediterranean diet will be defined as the degree to which toddlers' and parents' food intake aligns with core Mediterranean diet principles (high intake of fruits, vegetables, legumes, whole grains, fish, and healthy fats; limited red meat, processed foods, and added sugars). Adherence will be assessed using the KIDMED 2.0 questionnaire for toddlers and a validated Mediterranean Diet Adherence Screener (MEDAS) for parents, weekly for the first 3 weeks and every two weeks for the remaining 9 weeks. Scores range from 0 to 12 for toddlers and 0 to 14 for parents, with higher scores indicating greater adherence.

  Baseline, at 3 weeks, and at 3 months after enrollment.

• Program Feasibility and Acceptability

  Feasibility will be assessed via recruitment, retention, adherence to diet, attendance at nutrition sessions, and completion of study measures. Acceptability will be assessed through parent-reported satisfaction surveys regarding the diet and education program.

  Ongoing throughout study (baseline to 3 months).

• Children's Dietary Inflammatory Index (C-DII)

  The Children's Dietary Inflammatory Index (C-DII) quantifies the inflammatory potential of an individual's diet. For this study, toddler dietary intake obtained from 24-hour dietary recalls (one weekday and one weekend per week for first 3 weeks, every two weeks for final 9 weeks) will be used to calculate C-DII scores. The DII scoring algorithm assigns weights to nutrient and food component intake based on their established inflammatory properties. Higher DII scores indicate more pro-inflammatory dietary patterns, whereas lower (more negative) scores represent more anti-inflammatory diets aligned with Mediterranean-style eating.

  Baseline, at 3 weeks, and at 3 months after enrollment.

Secondary Outcomes (3)

• Gut Microbiome Diversity, Composition, and Metabolites

  Baseline, at 3 weeks, and at 3 months after enrollment.

• Toddler Anthropometrics, Body Composition, and Blood Pressure

  Baseline, at 3 weeks, and at 3 months after enrollment.

• Nutrition-Related Behaviors and Feeding Practices

  Baseline, at 3 weeks, and at 3 months after enrollment.

Study Arms (2)

Mediterranean Diet Intervention

EXPERIMENTAL

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.

Behavioral: Mediterranean Diet Nutrition Program

Standard Diet

ACTIVE COMPARATOR

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.

Behavioral: Standard Diet Education Program

Interventions

Mediterranean Diet Nutrition Program BEHAVIORAL

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.

Mediterranean Diet Intervention

Standard Diet Education Program BEHAVIORAL

A nine 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.

Standard Diet

Eligibility Criteria

• Age: 24 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent is ≥19 years of age.
• 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.

You may not qualify if:

• Toddler has food allergies or dietary restrictions (e.g., gluten-free) that make it difficult to follow a Mediterranean diet.
• 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.

Sponsors & Collaborators

• University of New Brunswick: lead

Study Sites (1)

University of New Brunswick

Fredericton, New Brunswick, E3B 4J9, Canada

Location

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Related Links

• Kebbe M. Nutribiomes Youtube Channel.
• World Health Organization. (2018). Noncommunicable diseases fact sheet.
• Statistics Canada. (2020). Leading causes of death, total population, by age group. Accessed August 20, 2024.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Maryam Kebbe, PhD, CLC

  University of New Brunswick

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Maryam Kebbe, PhD, CLC

CONTACT

15064516872; maryam.kebbe@unb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2025-12

Locations

CA (1)