Complementary Weaning With Adult Food Typical of the Mediterranean Diet

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

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 Overview

• Status: Completed
• Conditions: Weaning
• Intervention / Treatment: Dietary supplement: Mediterranean Diet weaning scheme

• Study Type: Interventional
• Enrollment (Actual): 394
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Mediterranean Diet group	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 12, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Complementary feeding; Mediterranean Diet; Microbioma
• Other Study ID Numbers: 213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No