Complementary Weaning With Adult Food Typical of the Mediterranean Diet

Federico II University

Status: Completed

Conditions: Weaning

Treatments: Dietary Supplement: Mediterranean Diet weaning scheme

Study type: Interventional

Funder types: Other

Identifiers

NCT05297357

213

Details and patient eligibility

About

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

Enrollment: 394 patients

Sex: All

Ages: 4 to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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394 participants in 2 patient groups

Mediterranean Diet group

Experimental group

Treatment:

Dietary Supplement: Mediterranean Diet weaning scheme

Control group

No Intervention group