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

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
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
NCT ID
NCT02953522
First Posted
November 1, 2016
Last Updated
November 3, 2016
Sponsor
Federal University of Paraíba
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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