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

June 6, 2022 updated by: Roberto Berni Canani, MD, PhD, Federico II University

Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity at 24 Months in the Offspring

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • University of Naples Federico II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The effects of Mediterranean Diet in pregnancy on the occurrence of overweight/obesity at 24 months in the offspring
Time Frame: After 24 months from the delivery
The children body growth indices are evaluated at 24 months
After 24 months from the delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The effect of Mediterranean Diet pregnancy on the composition of maternal gut microbiota through analysis of gut microbiota composition.
Time Frame: after 9 months (at the end of the pregnancy)
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.
after 9 months (at the end of the pregnancy)
The effect of Mediterranean diet in pregnancy on the production of short chain fatty acids (butyrate and propionate) in the intestinal tract.
Time Frame: after 9 months (at the end of the pregnancy)
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/
after 9 months (at the end of the pregnancy)
The adherence to Mediterranean Diet in the enrolled women
Time Frame: from 0 to 9 months (at the end of pregnancy)
Women Mediterranean Diet adherence score is evaluated through the "Med Diet Score"
from 0 to 9 months (at the end of pregnancy)
The effect of dietary counseling on dietary habits
Time Frame: from 0 to 9 months (at the end of pregnancy)
The diet composition in macro- and micronutrients is evaluated
from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean diet in pregnancy on the maternal weight gain and complications
Time Frame: from 0 to 9 months (at the end of pregnancy)
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)
from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean diet in pregnancy on perinatal and fetal complications
Time Frame: from 0 to 9 months (at the end of pregnancy)
Perinatal and fetal complications occurrence are evaluated
from 0 to 9 months (at the end of pregnancy)
The effect of Mediterranean Diet in pregnancy on the duration of breastfeeding and the composition of breast milk
Time Frame: from 0 to 4 months lactation
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.
from 0 to 4 months lactation
The effect of Mediterranean Diet on the occurrence of allergies and use of antibiotics in the first 2 years of life.
Time Frame: Every 6 months from offspring birth to 2 years
The occurrence of allergies and the use of antibiotics in the first 2 years of life are evaluated
Every 6 months from offspring birth to 2 years
The effect of Mediterranean Diet on the epigenetic modulation of genes involved in the regulation of immune system and metabolic pathways in the offspring
Time Frame: At delivery
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
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federico II University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roberto Berni Canani, Department of Traslational Medical Science, University of Naples Federico II

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 298/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Food Allergy

Clinical Trials on mediterranean diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings