Clinical trial NCT05119868: Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergies
Obesity
Gestational Complications
Gestational Weight Gain
Perinatal Condition
Birth Weight
Chronic Diseases in Children
Breast Feeding
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 276
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of allergic disorders at 24 months of age in the offspring
timeFrame: 24 months from birth
Secondary outcomes:
measure: Maternal weight gain
timeFrame: From enrollment until delivery
measure: Pregnancy complications occurrence
timeFrame: From enrollment until delivery
measure: Perinatal complications occurrence
timeFrame: Delivery
measure: Neonatal birth weight
timeFrame: Delivery
measure: Body growth in the offspring
timeFrame: During the 24 months of life
measure: Occurrence of any other chronic disorders in the first 2 years of age in the offspring
timeFrame: During the 24 months of life
measure: Mother's gut microbiome metagenomic features
timeFrame: From enrollment until delivery
measure: Mother's gut microbiome metabolomic features
timeFrame: From enrollment until delivery
measure: Son's gut microbiome metagenomic features
timeFrame: During the 24 months of life
measure: Son's gut microbiome metabolomic features
timeFrame: During the 24 months of life
measure: Breastfeeding duration
timeFrame: During the 24 months of life
measure: Breast milk composition
timeFrame: During the 24 months of life
measure: Epigenetic modulation of genes involved in the regulation of immune system in the offspring
timeFrame: Delivery
measure: Epigenetic modulation of genes involved in the metabolic pathways in the offspring
timeFrame: Delivery
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
city: Naples
country: Italy
facility: Department of Traslational Medical Science
Study officials:
affiliation: Department of Traslational Medical Science at University of Naples Federico II
name: Roberto Berni Canani
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.