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

Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring: a Multi-center Randomised-controlled Trial (the PREMEDI Project)

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 Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Department of Traslational Medical Science - University of Naples Federico II
  • Naples, Italy, 80131
    • Not yet recruiting
    • Department of Traslational Medical Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal weight gain	The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain	From enrollment until delivery
Pregnancy complications occurrence	The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence	From enrollment until delivery
Perinatal complications occurrence	The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence	Delivery
Neonatal birth weight	The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices	Delivery
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
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
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
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
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
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
Breastfeeding duration	The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration	During the 24 months of life
Breast milk composition	The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition	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	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	Delivery

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Roberto Berni Canani, Department of Traslational Medical Science at University of Naples Federico II

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Anticipated): January 10, 2025
• Study Completion (Anticipated): January 10, 2026

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Disease Attributes; Body Weight Changes; Hypersensitivity; Chronic Disease; Body Weight; Birth Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 283/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No