Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study (NCT07309536)
Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES): A Randomized Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (8 items).
Location: University of New Brunswick — Fredericton, New Brunswick
Age range: 24 Months to 36 Months
🧪 Interventions in This Study
- Mediterranean Diet Nutrition Program (BEHAVIORAL)
- Standard Diet Education Program (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of New Brunswick — Fredericton, New Brunswick
📞 Contact the Study Coordinator
Phone: (506) 451-6872
Email: maryam.kebbe@unb.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.