WeaningNCT05297357
Complementary Weaning With Adult Food Typical of the Mediterranean Diet
A study testing Mediterranean Diet weaning scheme in people with Weaning, run by Federico II University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Weaning
- What is being tested?
- Mediterranean Diet weaning scheme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants, either breast fed or formula fed between 4 and 6 months of age
- Informed consent from at least one parent
Who cannot join
- Infants either with associated comorbidities or with low birth weight
About this study
Official title: Complementary Weaning With Adult Food Typical of the Mediterranean Diet and it Effect on Taste Development and Eating Habits of Children
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:
- medium-long term adherence of the children to the MD (Primary aim).
- familial eating habits to verify how many changes may come from an early education of the kid toward a Mediterranean eating style
- the BMI of the children
- gut microbiota composition
- Conditions
- Weaning
- Being tested
- Mediterranean Diet weaning scheme
- Keywords
- Complementary feeding, Mediterranean Diet, Microbioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet weaning schemeDietary supplement
Kids in experimental group were weaned by using fresh foods traditionally used in MD and appropriately adapted to infants including seasonal fruit and vegetables, various kinds of fresh blue fish, spices and herbs. No salt was used while a small amount of Parmesan cheese was added. No sugar was added to any meal.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet group | Experimental | Not described Receives: Dietary Supplement: Mediterranean Diet weaning scheme |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet
KidMed is a questionnaire measuring Mediterranean Diet Quality for children and adolescents. The final score ranges from from 0 to 12 where scores >=8 indicates optimal Mediterranean diet; score within range 4-7 suggest that an improvement is needed to adjust intake to Mediterranean patterns and score <=3 indicate very low diet quality.
Measured: 36 months
Secondary outcomes (4)
Average of the KidMed score
Measured: 36 months
Average children's BMI
Measured: 36 months
Proportion of overweight and obese children
Overweight and obesity were defined according to extra-centiles of the Italian BMI growth norms published in Cacciari et al. 2006.
Measured: 36 months
Variation of microbial communities between arms based on Bray-Curtis dissimilarity
Bray-Curtis dissimilarity estimates difference in microbial abundances between two samples. It ranges from 0 to 1. The greater the index value the larger the difference in species abundances between groups.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 May 2015
- Primary completion1 Jul 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WeaningStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Bruzzese, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297357
- Sponsor's protocol ID
- 213
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Franchis R, Bozza L, Cortese P, D'Antonio L, D'Avino A, Gasparini N, Ippolito G, Spadaro R, Tedesco M, Antignani A, De Filippis F, Valentino V, Auricchio R, Auricchio S, Bruzzese D. Can Early Nutrition Be Responsible for Future Gut Microbiota Changes and Different Health Outcomes? Nutrients. 2025 Nov 27;17(23):3721. doi: 10.3390/nu17233721.
PubMed 41374011
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Weaning With Adult Food Typical of the Mediterranean Diet and it Effect on Taste Development and Eating Habits of Children
- ClinicalTrials.gov ID
- NCT05297357
- Acronym / sponsor ID
- 213
- Conditions
- Weaning
- Keywords
- Complementary feeding, Mediterranean Diet, Microbioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- medium-long term adherence of the children to the MD (Primary aim).
- familial eating habits to verify how many changes may come from an early education of the kid toward a Mediterranean eating style
- the BMI of the children
- gut microbiota composition
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet group | Experimental | Dietary Supplement: Mediterranean Diet weaning scheme |
| Control group | No intervention | – |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants, either breast fed or formula fed between 4 and 6 months of age
- Informed consent from at least one parent
Key exclusion criteria (1 listed)
- Infants either with associated comorbidities or with low birth weight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean Diet weaning schemeKids in experimental group were weaned by using fresh foods traditionally used in MD and appropriately adapted to infants including seasonal fruit and vegetables, various kinds of fresh blue fish, spices and herbs. No salt was used while a small amount of Parmesan cheese was added. No sugar was added to any meal. | Dietary supplement | Mediterranean Diet group |
Primary outcome
Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet
Time frame: 36 months
KidMed is a questionnaire measuring Mediterranean Diet Quality for children and adolescents. The final score ranges from from 0 to 12 where scores >=8 indicates optimal Mediterranean diet; score within range 4-7 suggest that an improvement is needed to adjust intake to Mediterranean patterns and score <=3 indicate very low diet quality.
4 secondary outcomes
Average of the KidMed score
Time frame: 36 months
Average children's BMI
Time frame: 36 months
Proportion of overweight and obese children
Time frame: 36 months
Variation of microbial communities between arms based on Bray-Curtis dissimilarity
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Derived from this study: PubMed 41374011de Franchis R, Bozza L, Cortese P, D'Antonio L, D'Avino A, Gasparini N, Ippolito G, Spadaro R, Tedesco M, Antignani A, De Filippis F, Valentino V, Auricchio R, Auricchio S, Bruzzese D. Can Early Nutrition Be Responsible for Future Gut Microbiota Changes and Different Health Outcomes? Nutrients. 2025 Nov 27;17(23):3721. doi: 10.3390/nu17233721.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet weaning scheme in people with Weaning, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05297357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.