Weaning
Conditions
Keywords
Complementary feeding, Mediterranean Diet, Microbioma
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
Interventions
DIETARY_SUPPLEMENTMediterranean 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.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 6 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Average of the KidMed score | 36 months | — |
| Average children's BMI | 36 months | — |
| 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. |
Outcome results
None listed