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

NCT05119868 | Recruiting

• 1 other identifier: 283/21
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergies; Obesity; Gestational Complications; Gestational Weight Gain; Perinatal Condition; Birth Weight; Chronic Diseases in Children; Breast Feeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Maternal weight gain

  From enrollment until delivery

• Pregnancy complications occurrence

  From enrollment until delivery

• Perinatal complications occurrence

  Delivery

• Neonatal birth weight

  Delivery

• Body growth in the offspring

  During the 24 months of life

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

NO INTERVENTION

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

Interventions

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.

Group 1

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (2)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

RECRUITING

Department of Traslational Medical Science

Naples, 80131, Italy

NOT YET RECRUITING

Related Publications (1)

• Coppola S, Paparo L, Chiariotti L, Ercolini D, Nocerino R, de Giovanni di Santa Severina AF, Carucci L, De Filippis F, Agangi A, Napolitano M, Passariello A, Messina F, Berni Canani R. Effects of the Mediterranean Diet during pregnancy on the onset of allergy in at risk children: A study protocol of a multi-center, randomized- controlled, parallel groups, prospective trial (the PREMEDI study). Front Nutr. 2022 Oct 13;9:951223. doi: 10.3389/fnut.2022.951223. eCollection 2022.

  PMID: 36313083 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Obesity; Gestational Weight Gain; Birth Weight; Breast Feeding

Condition Hierarchy (Ancestors)

Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes; Feeding Behavior; Behavior

Study Officials

• Roberto Berni Canani

  Department of Traslational Medical Science at University of Naples Federico II

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Berni Canani

CONTACT

0817462680; berni@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: November 2, 2021
• Primary Completion: January 10, 2025
• Study Completion: March 10, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)