A Supervised Nutritional Program in Pregnancies and NF-κB Expression in Placenta

Sponsor
Materno-Perinatal Hospital of the State of Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT01667939
Collaborator
National Council of Science and Technology, Mexico (Other), Secretariat of Public Education (SEP) (Other)
26
1
2
24
1.1

Study Details

Study Description

Brief Summary

Nuclear factor kappa B (NF-κB) pathway and oxidative stress participate in endothelial dysfunction, which is one of the causes of preeclampsia. Among the human antioxidant mechanisms there are the enzymes catalase (CAT), glutathione peroxidase (GPx) and superoxide dismutase (SOD). Our aim was to measure NF-κB and oxidative stress in pregnant women submitted to an individualized diet during pregnancy.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Eating Index (HEI) in supervised pregnancies
Phase 1

Detailed Description

Obesity during pregnancy is associated with exaggerated metabolic adaptation, endothelial dysfunction and an increased risk of adverse pregnancy outcomes, including preeclampsia, a major cause of maternal and fetal morbidity and mortality characterized by increased blood pressure, proteinuria and edema, which affects approximately 3% to 7% of all pregnant women. Other risk factors, besides obesity, that increase the likelihood of developing preeclampsia include chronic hypertension, and diabetes mellitus.

Reactive oxygen species (ROS) [superoxide anions (•O2-), hydrogen peroxide (H2O2) and hydroxyl radicals (•OH)],5 interact with proteins, nucleic acids and lipids and in a process called lipid peroxidation (LPO), can cause severe cell and tissue damage. There is current evidence that ROS are common activators of nuclear factor-kappa B (NF-κB), a factor that initiates a systemic inflammatory process by promoting the synthesis of cytokines, interleukin (IL)-6, IL-8, monocyte chemotactic protein-1 (MCP-1) and expression of intercellular adhesion molecule (ICAM-1).

To maintain balance of the oxidative state, the human body possesses intracellular antioxidant enzyme systems, including superoxide dismutase (SOD, glutathione peroxidase (GPx), and catalase (CAT), which is located mainly in peroxisomes and cytoplasm of the cell.

The epidemiology of preeclampsia, which is more common among poor women, had previously suggested that nutrients may be involved in the disorder, unfortunately, the nutritional data obtained from women with the syndrome has been poorly defined.

The objective of this paper was to provide an overview of the biological plausibility and potential mechanisms underlying associations among maternal nutrition, oxidative stress in placenta and the risk of preeclampsia.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Supervised Nutritional Program in Pregnancies Diminish the NF-κB Expression in Placenta
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: pregnancy diet

Healthy Eating Index (HEI) in supervised pregnancies

Behavioral: Healthy Eating Index (HEI) in supervised pregnancies
Dietetic treatment was calculated according to height, weeks of gestation and weight, considering an energy intake of 30 kcal/kg of expected weight, distributing the resulting energy according to the percentage of macronutrients' adequation (55-65% carbohydrates, 10-20% fat and the remainder as proteins).16 On each nutritional visit, 24 hour dietary recall was done and analyzed using NutriKcal®VO software in order to evaluate the Healthy Eating Index (HEI), which is commonly employed to assess pregnant women's dietary adequacy (on a scale from 0-100), through the consumption of 12 components of food groups described previously. An improvement in diet was considered when the initial HEI score improved more than one point during the next nutritional assessment.
Other Names:
  • NutriKcal®VO software
  • No Intervention: unsupervised pregnancy

    women attending the obstetrics unit who did not follow a supervised diet

    Outcome Measures

    Primary Outcome Measures

    1. Placental expression of NF-κB [two years]

      measure of gene expression by real time PCR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 36 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women in their first trimester of pregnancy
    Exclusion Criteria:
    • multiple pregnancies

    • prior history of chronic-metabolic diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Materno-Perinatal Hospital "Mónica Pretelini" Toluca Mexico 50130

    Sponsors and Collaborators

    • Materno-Perinatal Hospital of the State of Mexico
    • National Council of Science and Technology, Mexico
    • Secretariat of Public Education (SEP)

    Investigators

    • Principal Investigator: Hugo Mendieta Zeron, PhD, Materno-Perinatal Hospital "Monica Pretelini"

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hugo Mendieta Zeron, General Internal Medicine, Researcher, Materno-Perinatal Hospital of the State of Mexico
    ClinicalTrials.gov Identifier:
    NCT01667939
    Other Study ID Numbers:
    • HMPMP05/06/09
    First Posted:
    Aug 17, 2012
    Last Update Posted:
    Aug 17, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Hugo Mendieta Zeron, General Internal Medicine, Researcher, Materno-Perinatal Hospital of the State of Mexico

    Study Results

    No Results Posted as of Aug 17, 2012