CompletedNot Applicable

Complementary Weaning With Adult Food Typical of the Mediterranean Diet

394 participantsStarted 2015-05-01

Plain-language summary

A Randomized Controlled Clinical Trials was conducted to study the medium-long term impact of a complementary weaning using adult foods typical of Mediterranean Diets (MD) on children taste development and eating habits, and on the microbiota composition. Main objectives were to assess the effect of such weaning scheme on: 1. medium-long term adherence of the children to the MD (Primary aim). 2. familial eating habits to verify how many changes may come from an early education of the kid toward a Mediterranean eating style 3. the BMI of the children 4. gut microbiota composition

Who can participate

Age range

4 Months – 6 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: * Infants, either breast fed or formula fed between 4 and 6 months of age * Informed consent from at least one parent Exclusion Criteria: * Infants either with associated comorbidities or with low birth weight

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

Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet

Timeframe: 36 months

Trial details

NCT IDNCT05297357

SponsorFederico II University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07-01

View on ClinicalTrials.gov More Weaning trials