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Polymorphism C677T MTHFR and Effects of Folate Intake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02953522
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : November 6, 2016
Information provided by (Responsible Party):
Marina Ramalho Ribeiro, Federal University of Paraíba

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Other: 191 mcg/day of Folate Other: 90 mcg / day of Folate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Polymorphism C677T MTHFR and Diet With Folate in Oxidative Stress, Lipid Profile and Homocysteine
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
191 mcg/day of Folate
Diet with 191 mcg/day of Folate
Other: 191 mcg/day of Folate
Diet containing 191 mcg / day of Folate

90 mcg/day of Folate
Diet with 90 mcg/day of Folate
Other: 90 mcg / day of Folate
Diet containing 90 mcg / day of Folate

Primary Outcome Measures :
  1. Change in value of total antioxidant capacity [ Time Frame: 8 weeks ]
    Change in value of total antioxidant capacity

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02953522

Sponsors and Collaborators
Federal University of Paraíba
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Study Director: Maria José Carvalho Costa, Doctor UFPB
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Responsible Party: Marina Ramalho Ribeiro, Nutritionist and Master Degree Student of Science of Nutrition, Federal University of Paraíba Identifier: NCT02953522    
Other Study ID Numbers: FUParaíbaa
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 6, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data of the participants are in the excel database
Keywords provided by Marina Ramalho Ribeiro, Federal University of Paraíba:
Oxidative stress
Overweight and Obesity
Additional relevant MeSH terms:
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Body Weight
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs