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Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet containing 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 Folate, Polymorphism, Overweight and Obesity, Inflammatory markers

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Drinkers, smokers or with 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

    Experimental

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Diet with 191 mcg/day of Folate

    Diet containing 90 mcg / day of Folate

    Outcomes

    Primary Outcome Measures

    Change in value of Interleukins
    Change in value of homocysteine

    Secondary Outcome Measures

    Change in value of TNF-α

    Full Information

    First Posted
    May 24, 2017
    Last Updated
    June 12, 2017
    Sponsor
    Federal University of Paraíba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03186196
    Brief Title
    Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers
    Official Title
    Influence of Polymorphism C677T MTHFR and Folate Intake in Interleukins, Homocysteine and TNF-α
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    May 1, 2017 (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 of the MTHFR gene is associated to several biochemicals imbalances, as changes in folic acid serum levels and some inflammatory markers, elevating the oxidative stress and increasing the risk of developing non communicable diseases (NCDs). Thus, a diet containing folate as a main antioxidant nutrient, could reduce not only the oxidative stress, but also has many others benefits for individuals with this genetic alteration, like the anti-inflammatory function, which could help restore the altered serum levels and minimizing or avoiding the development of future diseases. 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 in the inflammatory markers levels, such as homocysteine, Tumor Necrosis Factor alpha (TNF-α) and interleukins in women with overweight or obesity. This is an intervention study, double-blind, held in a city in northeastern Brazil, with a sample of 48 adult women (20-59 years old) with BMI among 26.19 kg / m² and 49.64 kg / m². In which we evaluated the TNF-α levels, Interleukins 1β, Interleukin 6, Interleukin 8, Interleukin 12p70, Interleukin 10, homocysteine, folic acid and in addition to these markers evaluation, were made the genotyping for the C677T polymorphism in the MTHFR gene and the food consumption assessment by the 24 hour dietary recall (24HR). For the intervention, the sample was divided by randomization into two groups, each one with 24 indivuals, receiving daily during 8 weeks, a salad with 300g vegetables containing 191 ug of folate for group 1 and 90 ug for group 2.
    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 we (teams of undergraduate researchers and graduates of Nutrition Course, masters and doctoral students of the Post Graduate Program in Nutrition Sciences (PPGCN) of UFPB) did home visits, applied questionnaires related to anthropometric and food intake assessment, by 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
    Folate, Polymorphism, Overweight and Obesity, Inflammatory markers

    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
    Group 1
    Arm Type
    Experimental
    Arm Description
    Diet with 191 mcg/day of Folate
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Diet containing 90 mcg / day of Folate
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Diet containing Folate
    Primary Outcome Measure Information:
    Title
    Change in value of Interleukins
    Time Frame
    8 weeks
    Title
    Change in value of homocysteine
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Change in value of TNF-α
    Time Frame
    8 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change in value of folic acid
    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 years old, with overweight or obesity Individuals of different socioeconomic conditions Users or not drugs Cognitive state preserved and accept participate Exclusion Criteria: Drinkers, smokers or with 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 de Carvalho Costa, PhD
    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 Folate Intake in Inflammatory Biomarkers

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