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Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers

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: NCT03186196
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Jéssica Vanessa de Carvalho Lisboa, Federal University of Paraíba

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Dietary Supplement: Diet containing 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 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.

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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: Influence of Polymorphism C677T MTHFR and Folate Intake in Interleukins, Homocysteine and TNF-α
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1
Diet with 191 mcg/day of Folate
Dietary Supplement: Diet containing Folate
Active Comparator: Group 2
Diet containing 90 mcg / day of Folate
Dietary Supplement: Diet containing Folate

Primary Outcome Measures :
  1. Change in value of Interleukins [ Time Frame: 8 weeks ]
  2. Change in value of homocysteine [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in value of TNF-α [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. Change in value of folic acid [ Time Frame: 8 weeks ]

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 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

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): NCT03186196

Sponsors and Collaborators
Federal University of Paraíba
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Study Director: Maria José de Carvalho Costa, PhD UFPB

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Responsible Party: Jéssica Vanessa de Carvalho Lisboa, Nutritionist and Master Degree Student of Science of Nutrition, Federal University of Paraíba Identifier: NCT03186196     History of Changes
Other Study ID Numbers: FUParaíbaaa
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
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 Jéssica Vanessa de Carvalho Lisboa, Federal University of Paraíba:
Overweight and Obesity
Inflammatory markers
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs