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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Nutritional intervention based on Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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<br>* 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.<br>|
| No Intervention: Group 2<br>Group 2 will receive standard obstetrical and gynecological follow-up alone | |

What is the study measuring?
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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 |