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

NCT07309536 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Standard Diet Education Program

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.

Sponsors & Collaborators

  • University of New Brunswick

    lead OTHER

Principal Investigators

  • Dr. Maryam Kebbe, PhD, CLC · University of New Brunswick

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-04-01
Completion
2027-11-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309536 on ClinicalTrials.gov