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

Federico II University

Status: Enrolling

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

Treatments: Other: Nutritional intervention based on Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05119868

283/21

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Other: Nutritional intervention based on Mediterranean Diet

Group 2

No Intervention group

Description:

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