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

Dietary Habits Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667939
• Other study ID #: HMPMP05/06/09
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2012
• Last updated: August 16, 2012
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: Materno-Perinatal Hospital of the State of Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

Inclusion Criteria:

• Women in their first trimester of pregnancy

Exclusion Criteria:

• multiple pregnancies

• prior history of chronic-metabolic diseases

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dietary Habits

Intervention

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.

Locations

Country	Name	City	State
Mexico	Materno-Perinatal Hospital "Mónica Pretelini"	Toluca

Sponsors (3)

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

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placental expression of NF-?B	measure of gene expression by real time PCR	two years	No