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NCT Number: NCT01667939

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

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Feeding Behavior

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, State of Mexico, 50130, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women in their first trimester of pregnancy

Exclusion criteria

  • multiple pregnancies
  • prior history of chronic-metabolic diseases

Treatment and study plan

Healthy Eating Index (HEI) in supervised pregnancies

Behavioral

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

Primary outcomes

  1. Placental expression of NF-κB

    Time frame: two years

    measure of gene expression by real time PCR

Sponsors and collaborators

Lead sponsor

Materno-Perinatal Hospital of the State of Mexico

Other

Collaborators

  • National Council of Science and Technology, Mexico
  • Secretariat of Public Education (SEP)

Registry information

Official study title

A Supervised Nutritional Program in Pregnancies Diminish the NF-κB Expression in Placenta

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 17, 2012
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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