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

Primary Purpose

Allergies, Obesity, Gestational Complications

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nutritional intervention based on Mediterranean Diet
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Allergies

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Traslational Medical Science - University of Naples Federico IIRecruiting
  • Department of Traslational Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1

Group 2

Arm Description

Group 1 will receive standard obstetrical and gynecological follow-up and nutritional intervention based on Mediterranean Diet provided by certified dietitians

Group 2 will receive standard obstetrical and gynecological follow-up alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maternal weight gain
The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain
Pregnancy complications occurrence
The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence
Perinatal complications occurrence
The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence
Neonatal birth weight
The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices
Body growth in the offspring
The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring
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
Mother's gut microbiome metagenomic features
The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features
Mother's gut microbiome metabolomic features
The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features
Son's gut microbiome metagenomic features
The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features
Son's gut microbiome metabolomic features
The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features
Breastfeeding duration
The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration
Breast milk composition
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
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
The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the metabolic pathways in the offspring

Full Information

First Posted
November 3, 2021
Last Updated
April 14, 2023
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT05119868
Brief Title
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
Acronym
PREMEDI
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
January 10, 2025 (Anticipated)
Study Completion Date
January 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergies, Obesity, Gestational Complications, Gestational Weight Gain, Perinatal Condition, Birth Weight, Chronic Diseases in Children, Breast Feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1 will receive standard obstetrical and gynecological follow-up and nutritional intervention based on Mediterranean Diet provided by certified dietitians
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
Group 2 will receive standard obstetrical and gynecological follow-up alone
Intervention Type
Other
Intervention Name(s)
Nutritional intervention based on Mediterranean Diet
Intervention Description
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 Measure Information:
Title
Occurrence of allergic disorders at 24 months of age in the offspring
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on the occurrence of allergic disorders at 24 months of age in the offspring
Time Frame
24 months from birth
Secondary Outcome Measure Information:
Title
Maternal weight gain
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on maternal weight gain
Time Frame
From enrollment until delivery
Title
Pregnancy complications occurrence
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on pregnancy complications occurrence
Time Frame
From enrollment until delivery
Title
Perinatal complications occurrence
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on perinatal complications occurrence
Time Frame
Delivery
Title
Neonatal birth weight
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on neonatal growth indices
Time Frame
Delivery
Title
Body growth in the offspring
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on body growth in the offspring
Time Frame
During the 24 months of life
Title
Occurrence of any other chronic disorders in the first 2 years of age in the offspring
Description
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
Time Frame
During the 24 months of life
Title
Mother's gut microbiome metagenomic features
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metagenomic features
Time Frame
From enrollment until delivery
Title
Mother's gut microbiome metabolomic features
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on the mother's gut microbiome metabolomic features
Time Frame
From enrollment until delivery
Title
Son's gut microbiome metagenomic features
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metagenomic features
Time Frame
During the 24 months of life
Title
Son's gut microbiome metabolomic features
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on the son's gut microbiome metabolomic features
Time Frame
During the 24 months of life
Title
Breastfeeding duration
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on the breastfeeding duration
Time Frame
During the 24 months of life
Title
Breast milk composition
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on the breast milk composition
Time Frame
During the 24 months of life
Title
Epigenetic modulation of genes involved in the regulation of immune system in the offspring
Description
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
Time Frame
Delivery
Title
Epigenetic modulation of genes involved in the metabolic pathways in the offspring
Description
The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the metabolic pathways in the offspring
Time Frame
Delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Berni Canani
Phone
0817462680
Email
berni@unina.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani
Organizational Affiliation
Department of Traslational Medical Science at University of Naples Federico II
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Traslational Medical Science - University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani, MD, PhD
Phone
0817462680
Email
berni@unina.it
Facility Name
Department of Traslational Medical Science
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani
Phone
0817462680
Email
berni@unina.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36313083
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.
Results Reference
derived

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

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