Complementary Weaning With Adult Food Typical of the Mediterranean Diet

Not Applicable

Completed

• Conditions: Weaning
• Interventions: Dietary Supplement: Mediterranean Diet weaning scheme

• Registration Number: NCT05297357
• Lead Sponsor: Federico II University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2016-07-01
• Study Completion: 2019-12-31
• Status Verified: 2022-03
• Study First Submitted: 2022-03-12
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-03-28
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean Diet group	Mediterranean Diet weaning scheme	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of overweight and obese children	36 months	Overweight and obesity were defined according to extra-centiles of the Italian BMI growth norms published in Cacciari et al. 2006.
Variation of microbial communities between arms based on Bray-Curtis dissimilarity	48 months	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.
Average of the KidMed score	36 months
Average children's BMI	36 months