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

Sponsor

Federico II University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05119868

Collaborator

(none)

276

Enrollment

Locations

Arms

Anticipated Duration (Months)

138

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergies Obesity Gestational Complications Gestational Weight Gain Perinatal Condition Birth Weight Chronic Diseases in Children Breast Feeding	Other: Nutritional intervention based on Mediterranean Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

276 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official 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)

Anticipated Study Start Date :

Sep 10, 2022

Anticipated Primary Completion Date :

Jan 10, 2025

Anticipated Study Completion Date :

Jan 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Group 1 will receive standard obstetrical and gynecological follow-up and nutritional intervention based on Mediterranean Diet provided by certified dietitians	Other: Nutritional intervention based on Mediterranean Diet 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.
No Intervention: Group 2 Group 2 will receive standard obstetrical and gynecological follow-up alone

Arm

Intervention/Treatment

Experimental: Group 1

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

Other: Nutritional intervention based on Mediterranean Diet

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.

No Intervention: Group 2

Group 2 will receive standard obstetrical and gynecological follow-up alone

Outcome Measures

Primary Outcome Measures

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

Maternal weight gain [From enrollment until delivery]
The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain
Pregnancy complications occurrence [From enrollment until delivery]
The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence
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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Traslational Medical Science - University of Naples Federico II	Naples		Italy	80131
2	Department of Traslational Medical Science	Naples		Italy	80131