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

Not Applicable

Recruiting

• Conditions: Obesity; Gestational Complications; Allergies; Gestational Weight Gain; Perinatal Condition; Chronic Diseases in Children; Breast Feeding; Birth Weight
• Interventions: Other: Nutritional intervention based on Mediterranean Diet

• Registration Number: NCT05119868
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-02
• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2025-01-10
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Nutritional intervention based on Mediterranean Diet	Group 1 will receive standard obstetrical and gynecological follow-up and nutritional intervention based on Mediterranean Diet provided by certified dietitians

Primary Outcome Measures

Name	Time	Method
Occurrence of allergic disorders at 24 months of age in the offspring	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 Outcome Measures

Name	Time	Method
Mother's gut microbiome metagenomic features	From enrollment until delivery	The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features
Mother's gut microbiome metabolomic features	From enrollment until delivery	The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features
Son's gut microbiome metagenomic features	During the 24 months of life	The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features
Perinatal complications occurrence	Delivery	The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence
Neonatal birth weight	Delivery	The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices
Body growth in the offspring	During the 24 months of life	The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring
Pregnancy complications occurrence	From enrollment until delivery	The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence
Epigenetic modulation of genes involved in the regulation of immune system in the offspring	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
Epigenetic modulation of genes involved in the metabolic pathways in the offspring	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
Maternal weight gain	From enrollment until delivery	The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain
Occurrence of any other chronic disorders in the first 2 years of age in the offspring	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
Son's gut microbiome metabolomic features	During the 24 months of life	The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features
Breastfeeding duration	During the 24 months of life	The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration
Breast milk composition	During the 24 months of life	The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition

Trial Locations

Locations (2)

Department of Traslational Medical Science - University of Naples Federico II; 🇮🇹 Naples, Italy

Department of Traslational Medical Science; 🇮🇹 Naples, Italy