Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (… (NCT07309536) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study
Canada40 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
24 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mediterranean Diet Adherence
Timeframe: Baseline, at 3 weeks, and at 3 months after enrollment.
2
Program Feasibility and Acceptability
Timeframe: Ongoing throughout study (baseline to 3 months).
3
Children's Dietary Inflammatory Index (C-DII)
Timeframe: Baseline, at 3 weeks, and at 3 months after enrollment.