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

Browse trials for

• Overweight 3,644
• Food Hypersensitivity 338

Study arms

• No intervention
  Pregnant women at standard diet

  obstetrical and gynecological follow-up

• Experimental
  Pregnant women at mediterranean diet

  obstetrical and gynecological follow-up + nutritional counseling

  Behavioral: mediterranean diet

Interventions

• Behavioralmediterranean diet

  The Mediterranean diet (MD) is highly regarded as a healthy balanced diet. It is distinguished by a beneficial fatty acid profile that is rich in both monounsaturated and polyunsaturated fatty acids, high levels of polyphenols and other antioxidants, high intake of fiber and other low glycemic carbohydrates, and relatively greater vegetable than animal protein intake. Specifically, olive oil, assorted fruits, vegetables, cereals, legumes, and nuts; moderate consumption of fish, poultry, and red wine; and a lower intake of dairy products, red meat, processed meat and sweets characterize the traditional MD.

Primary outcomes

1. The effects of Mediterranean Diet in pregnancy on the occurrence of overweight/obesity at 24 months in the offspring

   The children body growth indices are evaluated at 24 months

   Time frame: After 24 months from the delivery

Secondary outcomes

1. The effect of Mediterranean Diet pregnancy on the composition of maternal gut microbiota through analysis of gut microbiota composition.

   Fecal bacteria DNA will be extracted using standard technique outlined by the Earth Microbiome Project. 16S V4-region amplicon libraries will be produced using previously described primers and sequenced using the IlluminaMiSeqplatform (150bpx2). Bacterial load will be determined by qPCR using a standard curve derived from a plasmid containing a single copy of the 16S rRNAencoding gene. Sequence data has been deposited in MG RAST under accession numbers 4571868.3-4571924.3 and project number 10023. Paired end reads will be quality trimmed and processed for OTU (operational taxonomic unit) clustering using UPARSE pipeline, set at 0.97% identity cutoff. Taxonomic status will be assigned to the high quality (\<1% incorrect bases) candidate OTUs using the "parallel_assign_taxonomy_rdp.py" script of QIIME software. Multiple sequence alignment and phylogenetic reconstruction will be performed using PyNast and FastTree.

   Time frame: after 9 months (at the end of the pregnancy)

2. The effect of Mediterranean diet in pregnancy on the production of short chain fatty acids (butyrate and propionate) in the intestinal tract.

   Fecal SCFAs concentration Frozen feces weighing 1g will be diluted with saline solution, vortexed, and centrifuged. Supernatants will be filtered and stored at -20°C until analysis. Frozen fecal extracts will be acidified and extracted in duplicate. A quantity of the pooled extract containing acidified butyrate, propionate or acetate will be transferred into a 2ml glass vial and loaded onto an Agilent Technologies 7890 gas chromatograph (GC) system. Detection will be achieved using a flame ionization detector. Peaks will be identified using a mixed external standard and quantified by peak height/internal standard ratio. To examine whether fecal butyrate levels correlates with bacterial diversity (Shannon diversity index) and evenness (Pielou's evenness index) and abundance patterns across multiple groups we will calculate the Spearman correlation using the cor.test function implemented in R (http://www.r-project.org/

   Time frame: after 9 months (at the end of the pregnancy)

3. The adherence to Mediterranean Diet in the enrolled women

   Women Mediterranean Diet adherence score is evaluated through the "Med Diet Score"

   Time frame: from 0 to 9 months (at the end of pregnancy)

4. The effect of dietary counseling on dietary habits

   The diet composition in macro- and micronutrients is evaluated

   Time frame: from 0 to 9 months (at the end of pregnancy)

5. The effect of Mediterranean diet in pregnancy on the maternal weight gain and complications

   To evaluate the effect of Mediterranean diet in pregnancy on the maternal weight gain and complications (gestational hypertension, infections, gestational diabetes, preeclampsia, use of cesarean)

   Time frame: from 0 to 9 months (at the end of pregnancy)

6. The effect of Mediterranean diet in pregnancy on perinatal and fetal complications

   Perinatal and fetal complications occurrence are evaluated

   Time frame: from 0 to 9 months (at the end of pregnancy)

7. The effect of Mediterranean Diet in pregnancy on the duration of breastfeeding and the composition of breast milk

   The effect of Mediterranean Diet in pregnancy on the duration of breastfeeding and the composition of breast milk (short chain fatty acids, bacterial DNA, adipocytokines.

   Time frame: from 0 to 4 months lactation

8. The effect of Mediterranean Diet on the occurrence of allergies and use of antibiotics in the first 2 years of life.

   The occurrence of allergies and the use of antibiotics in the first 2 years of life are evaluated

   Time frame: Every 6 months from offspring birth to 2 years

9. The effect of Mediterranean Diet on the epigenetic modulation of genes involved in the regulation of immune system and metabolic pathways in the offspring

   The evaluation of the effect of Mediterranean Diet during pregnancy on the epigenetic modulation of genes involved in the immune system and metabolic pathways in the offspring through the cord blood epigenome-wide association study

   Time frame: At delivery

Individual participant data

Plan to share: No