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Completed

NCT Number: NCT05297357

Complementary Weaning With Adult Food Typical of the Mediterranean Diet

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

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Key information

Conditions

Weaning

Age range

4 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet weaning scheme

Dietary Supplement

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.

Primary outcomes

  1. Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet

    Time frame: 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 outcomes

  1. Average of the KidMed score

    Time frame: 36 months

  2. Average children's BMI

    Time frame: 36 months

  3. Proportion of overweight and obese children

    Time frame: 36 months

    Overweight and obesity were defined according to extra-centiles of the Italian BMI growth norms published in Cacciari et al. 2006.

  4. Variation of microbial communities between arms based on Bray-Curtis dissimilarity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Mar 28, 2022
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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