Complementary Weaning With Adult Food Typical of the Mediterranean Diet

Federico II University394 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

394

Conditions

Weaning

Interventions

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.

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 36 months

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

Overweight and obesity were defined according to extra-centiles of the Italian BMI growth norms published in Cacciari et al. 2006.

Time frame: 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.

Time frame: 48 months

Data from ClinicalTrials.gov

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