Complementary Weaning With Adult Food Typical of the Mediterranean Diet

Weaning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297357
• Other study ID #: 213
• Status: Completed
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2022
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: December 31, 2019
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Weaning

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average of the KidMed score		36 months
Secondary	Average children's BMI		36 months
Secondary	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
Secondary	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