Clinical trial NCT03337802: Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring
Official title: Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity at 24 Months in the Offspring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effects of Mediterranean Diet in pregnancy on the occurrence of overweight/obesity at 24 months in the offspring
timeFrame: After 24 months from the delivery
Secondary outcomes:
measure: The effect of Mediterranean Diet pregnancy on the composition of maternal gut microbiota through analysis of gut microbiota composition.
timeFrame: after 9 months (at the end of the pregnancy)
measure: The effect of Mediterranean diet in pregnancy on the production of short chain fatty acids (butyrate and propionate) in the intestinal tract.
timeFrame: after 9 months (at the end of the pregnancy)
measure: The adherence to Mediterranean Diet in the enrolled women
timeFrame: from 0 to 9 months (at the end of pregnancy)
measure: The effect of dietary counseling on dietary habits
timeFrame: from 0 to 9 months (at the end of pregnancy)
measure: The effect of Mediterranean diet in pregnancy on the maternal weight gain and complications
timeFrame: from 0 to 9 months (at the end of pregnancy)
measure: The effect of Mediterranean diet in pregnancy on perinatal and fetal complications
timeFrame: from 0 to 9 months (at the end of pregnancy)
measure: The effect of Mediterranean Diet in pregnancy on the duration of breastfeeding and the composition of breast milk
timeFrame: from 0 to 4 months lactation
measure: The effect of Mediterranean Diet on the occurrence of allergies and use of antibiotics in the first 2 years of life.
timeFrame: Every 6 months from offspring birth to 2 years
measure: The effect of Mediterranean Diet on the epigenetic modulation of genes involved in the regulation of immune system and metabolic pathways in the offspring
timeFrame: At delivery
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: Department of Traslational Medical Science, University of Naples Federico II
name: Roberto Berni Canani
role: PRINCIPAL_INVESTIGATOR
References: