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

NCT ID: NCT01667939

Last Updated: 2012-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-06-30

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.

Conditions

Dietary Habits

Keywords

adequacy; diet; pregnancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

pregnancy diet

Healthy Eating Index (HEI) in supervised pregnancies

Group Type: EXPERIMENTAL

Healthy Eating Index (HEI) in supervised pregnancies

Intervention Type: 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.

unsupervised pregnancy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

NutriKcal®VO software

Eligibility Criteria

Inclusion Criteria

• Women in their first trimester of pregnancy

Exclusion Criteria

• multiple pregnancies
• prior history of chronic-metabolic diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Secretariat of Public Education (SEP)

UNKNOWN

Sponsor Role: collaborator

Materno-Perinatal Hospital of the State of Mexico

OTHER

Sponsor Role: lead

Responsible Party

Hugo Mendieta Zeron

General Internal Medicine, Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hugo Mendieta Zeron, PhD

Role: PRINCIPAL_INVESTIGATOR

Materno-Perinatal Hospital "Monica Pretelini"

Locations

Materno-Perinatal Hospital "Mónica Pretelini"

Toluca, State of Mexico, Mexico

Countries

Mexico

Other Identifiers

HMPMP05/06/09

Identifier Type: -

Identifier Source: org_study_id