Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring (PREMEDI)

Federico II University

Status: Completed

Conditions: Food Allergy

Treatments: Behavioral: mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03337802

298/16

Details and patient eligibility

About

The first 1,000 days of life, from the conception to 24 months, are crucial to achieve long-term health outcomes and represent a strategic period to intervene under prevention and public health perspective. Nutritional exposures during this critical period of life can influence the future disease susceptibility. Maternal diet during pregnancy has been linked to offspring overweight/obesity risk and it could represent a potential target for overweight/obesity prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models, which impacts beneficially the gut microbiome (GM), providing high amounts of fiber, antioxidants polyphenols and vitamins, and a balanced ratio of essential fatty acids (ω6:ω3). Notably, the MD beneficial effects are due to the synergistic and interactive combinations of nutrients, and the modulation of gene expression through epigenetic changes. Unofrtunately, the MD mechanisms during pregnancy in the prevention of childhood overweight/obesity are not yet fully known.

Full description

The PREMEDI study has been designed to evaluate the effects of Mediterranean Diet during pregnancy on the occurrence of overweight/obesity at 24 months in the offspring.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women
• caucasian ethnicity
• aged between 20 and 35 years

Exclusion criteria

• proven presence of infections during pregnancy and at delivery,
• twin pregnancy,
• ongoing malignancies,
• major gastrointestinal tract malformations,
• immunodeficiencies,
• diabetes and other chronic diseases at each organ or apparatus level,
• chronic intestinal inflammatory diseases,
• gastrointestinal function disorders,
• celiac disease;
• history of abdominal surgery with intestinal resection,
• neuropsychiatric disorders,
• central nervous system disorders,
• vegan diet.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pregnant women at standard diet

No Intervention group

Description:

obstetrical and gynecological follow-up

Pregnant women at mediterranean diet

Experimental group

Description:

obstetrical and gynecological follow-up + nutritional counseling

Treatment:

Behavioral: mediterranean diet