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NCT Number: NCT05119868

Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring

Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.

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Key information

Conditions

Allergies Behavior Birth Weight Body Weight Body Weight Changes Breast Feeding Chronic Diseases in Children Feeding Behavior Gestational Complications Gestational Weight Gain Hypersensitivity Immune System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Perinatal Condition Signs and Symptoms Weight Gain

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Traslational Medical Science, Naples, Italy

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby

Exclusion criteria

  • concomitant presence of infections;
  • concomitant presence of malignancies;
  • concomitant presence of major gastrointestinal malformations;
  • concomitant presence of immunodeficiencies;
  • concomitant presence of autoimmune diseases;
  • concomitant presence of chronic inflammatory bowel diseases;
  • concomitant presence of functional gastrointestinal disorders;
  • concomitant presence of celiac disease;
  • history of abdominal surgery with gastrointestinal resection;
  • concomitant presence of neuropsychiatric disorders;
  • concomitant presence of central nervous system disorders;
  • vegan diet;
  • twin pregnancy;
  • concomitant presence of genetic disorders;
  • concomitant presence of metabolic disorders.

Treatment and study plan

Nutritional intervention based on Mediterranean Diet

Other

A personalized nutritional counseling and a tailored diet, according to Mediterranean dietary pattern, designed on the pre-pregnancy weight, height and trimester of pregnancy provided by certified dietitians.

Primary outcomes

  1. Occurrence of allergic disorders at 24 months of age in the offspring

    Time frame: 24 months from birth

    The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of allergic disorders at 24 months of age in the offspring

Secondary outcomes

  1. Maternal weight gain

    Time frame: From enrollment until delivery

    The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain

  2. Pregnancy complications occurrence

    Time frame: From enrollment until delivery

    The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence

  3. Perinatal complications occurrence

    Time frame: Delivery

    The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence

  4. Neonatal birth weight

    Time frame: Delivery

    The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices

  5. Body growth in the offspring

    Time frame: During the 24 months of life

    The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring

  6. Occurrence of any other chronic disorders in the first 2 years of age in the offspring

    Time frame: During the 24 months of life

    The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of any other chronic disorders in the first 2 years of age in the offspring

  7. Mother's gut microbiome metagenomic features

    Time frame: From enrollment until delivery

    The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features

  8. Mother's gut microbiome metabolomic features

    Time frame: From enrollment until delivery

    The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features

  9. Son's gut microbiome metagenomic features

    Time frame: During the 24 months of life

    The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features

  10. Son's gut microbiome metabolomic features

    Time frame: During the 24 months of life

    The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features

  11. Breastfeeding duration

    Time frame: During the 24 months of life

    The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration

  12. Breast milk composition

    Time frame: During the 24 months of life

    The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition

  13. Epigenetic modulation of genes involved in the regulation of immune system in the offspring

    Time frame: Delivery

    The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the regulation of immune system in the offspring

  14. Epigenetic modulation of genes involved in the metabolic pathways in the offspring

    Time frame: Delivery

    The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the metabolic pathways in the offspring

  15. To validate a digital app

    Time frame: During the first 1000 days

    Validate an app designed to promote a healthy lifestyle and prevent the most common non-communicable chronic diseases

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Berni Canani

CONTACT

[email protected]

0817462680

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring: a Multi-center Randomised-controlled Trial (the PREMEDI Project)

Acronym: PREMEDI

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 15, 2021
Registry last updated
Feb 12, 2026

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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