Allergies, Birth Weight, Breast Feeding, Chronic Diseases in Children, Gestational Complications, Gestational Weight Gain, Obesity, Perinatal Condition
Conditions
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.
Interventions
OTHERNutritional 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.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of allergic disorders at 24 months of age in the offspring | 24 months from birth | The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of allergic disorders at 24 months of age in the offspring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Son's gut microbiome metabolomic features | During the 24 months of life | The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features |
| Breastfeeding duration | During the 24 months of life | The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration |
| Breast milk composition | During the 24 months of life | The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition |
| Epigenetic modulation of genes involved in the regulation of immune system in the offspring | Delivery | 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 |
| Epigenetic modulation of genes involved in the metabolic pathways in the offspring | Delivery | The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the metabolic pathways in the offspring |
| To validate a digital app | During the first 1000 days | Validate an app designed to promote a healthy lifestyle and prevent the most common non-communicable chronic diseases |
| Mother's gut microbiome metagenomic features | From enrollment until delivery | The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features |
| Mother's gut microbiome metabolomic features | From enrollment until delivery | The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features |
| Maternal weight gain | From enrollment until delivery | The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain |
| Pregnancy complications occurrence | From enrollment until delivery | The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence |
| Perinatal complications occurrence | Delivery | The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence |
| Neonatal birth weight | Delivery | The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices |
| Body growth in the offspring | During the 24 months of life | The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring |
| Son's gut microbiome metagenomic features | During the 24 months of life | The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features |
| Occurrence of any other chronic disorders in the first 2 years of age in the offspring | During the 24 months of life | 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 |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORRoberto Berni Canani
Department of Traslational Medical Science at University of Naples Federico II
Outcome results
None listed