Polymorphism C677T MTHFR and Effects of Folate Intake

NCT02953522 | Completed DMC

• 1 other identifier: FUParaíbaa
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity

Keywords

Polymorphism; Folate; Oxidative stress; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Change in value of total antioxidant capacity

  Change in value of total antioxidant capacity

  8 weeks

Study Arms (2)

191 mcg/day of Folate

OTHER

Diet with 191 mcg/day of Folate

Other: 191 mcg/day of Folate

90 mcg/day of Folate

OTHER

Diet with 90 mcg/day of Folate

Other: 90 mcg / day of Folate

Interventions

191 mcg/day of Folate OTHER

Diet containing 191 mcg / day of Folate

191 mcg/day of Folate

90 mcg / day of Folate OTHER

Diet containing 90 mcg / day of Folate

90 mcg/day of Folate

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Paraíba: lead

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Maria José Carvalho Costa, Doctor

  UFPB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist and Master Degree Student of Science of Nutrition

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 7, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share