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

Obesity Clinical Trial

— PREMEDI  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119868
• Other study ID #: 283/21
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: January 10, 2026

Study information

• Verified date: April 2023
• Source: Federico II University
• Contact: Roberto Berni Canani
• Phone: 0817462680
• Email: berni[@]unina.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: January 10, 2026
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergies
• Birth Weight
• Body Weight
• Breast Feeding
• Chronic Disease
• Gestational Weight Gain
• Hypersensitivity
• Obesity
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science	Naples
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months from birth
Secondary	Maternal weight gain	The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain	From enrollment until delivery
Secondary	Pregnancy complications occurrence	The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence	From enrollment until delivery
Secondary	Perinatal complications occurrence	The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence	Delivery
Secondary	Neonatal birth weight	The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices	Delivery
Secondary	Body growth in the offspring	The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring	During the 24 months of life
Secondary	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	During the 24 months of life
Secondary	Mother's gut microbiome metagenomic features	The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features	From enrollment until delivery
Secondary	Mother's gut microbiome metabolomic features	The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features	From enrollment until delivery
Secondary	Son's gut microbiome metagenomic features	The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features	During the 24 months of life
Secondary	Son's gut microbiome metabolomic features	The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features	During the 24 months of life
Secondary	Breastfeeding duration	The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration	During the 24 months of life
Secondary	Breast milk composition	The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition	During the 24 months of life
Secondary	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	Delivery
Secondary	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	Delivery