A Supervised Nutritional Program in Pregnancies and NF-κB Expression in Placenta
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedAugust 17, 2012
August 1, 2012
1.5 years
August 15, 2012
August 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Placental expression of NF-κB
measure of gene expression by real time PCR
two years
Study Arms (2)
pregnancy diet
EXPERIMENTALHealthy Eating Index (HEI) in supervised pregnancies
unsupervised pregnancy
NO INTERVENTIONwomen attending the obstetrics unit who did not follow a supervised diet
Interventions
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.
Eligibility Criteria
You may qualify if:
- Women in their first trimester of pregnancy
You may not qualify if:
- multiple pregnancies
- prior history of chronic-metabolic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Materno-Perinatal Hospital "Mónica Pretelini"
Toluca, State of Mexico, 50130, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugo Mendieta Zeron, PhD
Materno-Perinatal Hospital "Monica Pretelini"
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- General Internal Medicine, Researcher
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
June 1, 2009
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
August 17, 2012
Record last verified: 2012-08