Complementary Weaning With Adult Food Typical of the Mediterranean Diet

Study Overview
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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: 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

Official Title
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Complementary Weaning With Adult Food Typical of the Mediterranean Diet and it Effect on Taste Development and Eating Habits of Children

Conditions
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Weaning

Intervention / Treatment
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* Dietary Supplement: Mediterranean Diet weaning scheme


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Diet group<br> | Dietary Supplement: Mediterranean Diet weaning scheme<br>* 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average of the KidMed score |  | 36 months | 
| Average children's BMI |  | 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. | 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. | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complementary feeding, Mediterranean Diet, Microbioma