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Polymorphism C677T MTHFR and Effects of Folate Intake

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
191 mcg/day of Folate
90 mcg / day of Folate
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Polymorphism, Folate, Oxidative stress, Overweight and Obesity

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult women, aged 20 to 59, sound overweight or obese
  • Individuals of different socioeconomic conditions
  • Users or not drugs
  • Cognitive state preserved and accept participate

Exclusion Criteria:

  • Drinkers, smokers or neuropsychiatric disorders
  • Users drugs known to interfere with the metabolism of folic acid (the last 3 months), as prednisone, hydrocortisone, dexamethasone, chloramphenicol, acetylsalicylic acid
  • Multivitamin supplement users, minerals, appetite suppressants and steroids
  • Individuals with chronic diseases with influence on the endocrine and metabolic system
  • Pregnant or planning to become pregnant during the study period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    191 mcg/day of Folate

    90 mcg/day of Folate

    Arm Description

    Diet with 191 mcg/day of Folate

    Diet with 90 mcg/day of Folate

    Outcomes

    Primary Outcome Measures

    Change in value of total antioxidant capacity
    Change in value of total antioxidant capacity

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2016
    Last Updated
    November 3, 2016
    Sponsor
    Federal University of Paraíba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02953522
    Brief Title
    Polymorphism C677T MTHFR and Effects of Folate Intake
    Official Title
    Polymorphism C677T MTHFR and Diet With Folate in Oxidative Stress, Lipid Profile and Homocysteine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Paraíba

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The C677T polymorphism in the MTHFR gene is related to several significant biochemical changes, as dyslipidemia, changes in serum levels of homocysteine, folic acid, vitamin B12 and some oxidative stress markers such as the CAT and MDA, leading to a high risk of the emergence of cardiovascular disease (CVD). A diet containing antioxidants, especially folate, is characterized by being beneficial for individuals with this genetic alteration to possess anti-inflammatory function, act on and oxidative stress play an important gene function. The aim of this study was to evaluate the influence of the C677T polymorphism of the MTHFR gene and the effect of a diet containing folate on oxidative stress, lipid profile and homocysteine levels in adult women are overweight or obese. This is an intervention study, double-blind, held in a city in northeastern Brazil. The study included 48 adult women (20-59 years old) with BMI of 26.19 kg / m² and 49.64 kg / m², in which we evaluated the CAT levels, MDA, lipid profile, folic acid, homocysteine and vitamin B12 addition genotyping for the C677T polymorphism in the MTHFR gene and the food consumption by the food recall 24 hours, being divided by randomization into two groups received daily for 8 weeks, 300g vegetables rich in folate containing 191 ug and 90 ug of this nutrient.
    Detailed Description
    This work is linked to a population-based survey entitled "Diagnosis and Intervention II Cycle Situation Food, Nutrition and Noncommunicable Diseases prevalent over the city of João Pessoa Population / PB" (II DISANDNT / PB). For the realization of this dissertation home visits and the questionnaires related to anthropometric and food intake assessment were conducted by teams of undergraduate researchers and graduates of Nutrition Course, masters and doctoral students of the Post Graduate Program in Nutrition Sciences (PPGCN) of UFPB duly previously trained at the beginning of data collection and after completion of the pilot study. After the selection of individuals from the sample of adults who participated in the II DISANDNT / JP and considering the inclusion criteria and genotyping of the C677T polymorphism in the MTHFR gene, they were invited to participate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity
    Keywords
    Polymorphism, Folate, Oxidative stress, Overweight and Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    191 mcg/day of Folate
    Arm Type
    Other
    Arm Description
    Diet with 191 mcg/day of Folate
    Arm Title
    90 mcg/day of Folate
    Arm Type
    Other
    Arm Description
    Diet with 90 mcg/day of Folate
    Intervention Type
    Other
    Intervention Name(s)
    191 mcg/day of Folate
    Intervention Description
    Diet containing 191 mcg / day of Folate
    Intervention Type
    Other
    Intervention Name(s)
    90 mcg / day of Folate
    Intervention Description
    Diet containing 90 mcg / day of Folate
    Primary Outcome Measure Information:
    Title
    Change in value of total antioxidant capacity
    Description
    Change in value of total antioxidant capacity
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult women, aged 20 to 59, sound overweight or obese Individuals of different socioeconomic conditions Users or not drugs Cognitive state preserved and accept participate Exclusion Criteria: Drinkers, smokers or neuropsychiatric disorders Users drugs known to interfere with the metabolism of folic acid (the last 3 months), as prednisone, hydrocortisone, dexamethasone, chloramphenicol, acetylsalicylic acid Multivitamin supplement users, minerals, appetite suppressants and steroids Individuals with chronic diseases with influence on the endocrine and metabolic system Pregnant or planning to become pregnant during the study period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria José Carvalho Costa, Doctor
    Organizational Affiliation
    UFPB
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The data of the participants are in the excel database

    Learn more about this trial

    Polymorphism C677T MTHFR and Effects of Folate Intake

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