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

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ClinicalTrials.gov Identifier: NCT01667939
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : August 17, 2012
Information provided by (Responsible Party):

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
Dietary Habits 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  (Clinical Trial)
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 : June 2009
Primary Completion Date : December 2010
Study Completion Date : June 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 Name: 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 [ Time Frame: two years ]
    measure of gene expression by real time PCR

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667939

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)
Principal Investigator: Hugo Mendieta Zeron, PhD Materno-Perinatal Hospital "Monica Pretelini"
More Information

Responsible Party: Hugo Mendieta Zeron, General Internal Medicine, Researcher, Materno-Perinatal Hospital of the State of Mexico
ClinicalTrials.gov Identifier: NCT01667939     History of Changes
Other Study ID Numbers: HMPMP05/06/09
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012

Keywords provided by Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico: