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Toddler diet study: could mediterranean eating shape lifelong health?

NCT ID NCT07309536

Knowledge-focused Sponsor: University of New Brunswick Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a Mediterranean diet can improve gut health, body composition, and inflammation in toddlers aged 2-3. Forty families will be randomly assigned to either a 3-week Mediterranean diet with free food boxes and nutrition education, or their usual diet. Researchers will track diet adherence, gut microbiome changes, and body measurements to see if early diet can set the stage for healthier eating habits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mediterranean diet (food provision and nutrition education program)
What this could lead to
If successful, this could show that a Mediterranean diet improves toddler gut health and reduces inflammation, guiding future dietary recommendations for young children.
What could go wrong
This is a small, early-stage study with only 40 toddlers, so results may not apply to all children. The diet is short-term (3 weeks), and long-term benefits are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

24 to 36 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Inflammation inflammatory disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adherence Body composition Gut microbiome Inflammation Metabolites

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of New Brunswick

    Fredericton, New Brunswick, E3B 4J9, Canada

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