Complementary Weaning With Adult Food Typical of the Mediterranean Diet

NCT ID: NCT05297357

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2019-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mediterranean Diet group

Group Type EXPERIMENTAL

Mediterranean Diet weaning scheme

Intervention Type DIETARY_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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mediterranean Diet weaning scheme

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

4 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Dario Bruzzese

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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213

Identifier Type: -

Identifier Source: org_study_id

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