Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nutritional intervention based on Mediterranean Diet.
- Who it may be relevant to
- Registry conditions: Allergies, Obesity, Gestational Complications, Gestational Weight Gain. Basic parameters: 20 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Occurrence of allergic disorders at 24 months of age in the offspring [Time frame: 24 months from birth]
Secondary outcome measures (12)
- Maternal weight gain [Time frame: From enrollment until delivery]
- Pregnancy complications occurrence [Time frame: From enrollment until delivery]
- Perinatal complications occurrence [Time frame: Delivery]
- Neonatal birth weight [Time frame: Delivery]
- Body growth in the offspring [Time frame: During the 24 months of life]
- Occurrence of any other chronic disorders in the first 2 years of age in the offspring [Time frame: During the 24 months of life]
- Mother's gut microbiome metagenomic features [Time frame: From enrollment until delivery]
- Mother's gut microbiome metabolomic features [Time frame: From enrollment until delivery]
- Son's gut microbiome metagenomic features [Time frame: During the 24 months of life]
- Son's gut microbiome metabolomic features [Time frame: During the 24 months of life]
- Breastfeeding duration [Time frame: During the 24 months of life]
- Breast milk composition [Time frame: During the 24 months of life]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 2 centers
- Department of Traslational Medical Science - University of Naples Federico II — Naples
- Department of Traslational Medical Science — Naples
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). Fro PMID 36313083
Identifiers
NCT: NCT05119868 · 283/21