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

N/ARecruitingNCT05119868

Federico II University276 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

276

Conditions

Allergies Obesity Gestational Complications Gestational Weight Gain Perinatal Condition

Interventions

Nutritional intervention based on Mediterranean DietOTHER

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Department of Traslational Medical Science - University of Naples Federico II

Naples, Italy

RECRUITING

Department of Traslational Medical Science

Naples, Italy

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: 24 months from birth

Secondary Outcomes

Maternal weight gain

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

Time frame: From enrollment until delivery

Pregnancy complications occurrence

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

Time frame: From enrollment until delivery

Perinatal complications occurrence

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

Time frame: Delivery

Neonatal birth weight

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

Time frame: Delivery

Body growth in the offspring

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

Time frame: During the 24 months of life

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

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

Time frame: During the 24 months of life

Mother's gut microbiome metagenomic features

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

Time frame: From enrollment until delivery

Mother's gut microbiome metabolomic features

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

Time frame: From enrollment until delivery

Son's gut microbiome metagenomic features

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

Time frame: During the 24 months of life

Son's gut microbiome metabolomic features

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

Time frame: During the 24 months of life

Breastfeeding duration

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

Time frame: During the 24 months of life

Breast milk composition

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

Time frame: During the 24 months of life

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

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

Time frame: Delivery

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

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

Time frame: Delivery

To validate a digital app

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

Time frame: During the first 1000 days

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts