Clinical trial NCT01667939: A Supervised Nutritional Program in Pregnancies and NF-κB Expression in Placenta
Official title: A Supervised Nutritional Program in Pregnancies Diminish the NF-κB Expression in Placenta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dietary Habits
Keywords: adequacy
diet
pregnancy
Lead sponsor: Materno-Perinatal Hospital of the State of Mexico
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
name: Secretariat of Public Education (SEP)
First posted: 2012-08-17
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Women in their first trimester of pregnancy

Exclusion Criteria:

* multiple pregnancies
* prior history of chronic-metabolic diseases

Primary outcomes:
measure: Placental expression of NF-κB
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Toluca
country: Mexico
facility: Materno-Perinatal Hospital "Mónica Pretelini"
Study officials:
affiliation: Materno-Perinatal Hospital "Monica Pretelini"
name: Hugo Mendieta Zeron, PhD
role: PRINCIPAL_INVESTIGATOR
References: