Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 will receive standard obstetrical and gynecological follow-up and nutritional intervention based on Mediterranean Diet provided by certified dietitians |
|
| Group 2 | No Intervention | Group 2 will receive standard obstetrical and gynecological follow-up alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional intervention based on Mediterranean Diet | Other | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
- healthy women (aged 20-35 years), at first trimester of pregnancy, of at risk for atopy baby
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Berni Canani | Contact | 0817462680 | berni@unina.it |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Berni Canani | Department of Traslational Medical Science at University of Naples Federico II | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Traslational Medical Science - University of Naples Federico II | Recruiting | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36313083 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| To validate a digital app | Validate an app designed to promote a healthy lifestyle and prevent the most common non-communicable chronic diseases | During the first 1000 days |
| Department of Traslational Medical Science | Not yet recruiting | Naples | 80131 | Italy |
|
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D009765 | Obesity |
| D000078064 | Gestational Weight Gain |
| D001724 | Birth Weight |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided