Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers

NCT03186196 | Completed DMC

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

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.

Conditions

Overweight and Obesity

Keywords

Folate; Polymorphism; Overweight and Obesity; Inflammatory markers

Outcome Measures

Primary Outcomes (2)

• Change in value of Interleukins

  8 weeks

• Change in value of homocysteine

  8 weeks

Secondary Outcomes (1)

• Change in value of TNF-α

  8 weeks

Other Outcomes (1)

• Change in value of folic acid

  8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Diet with 191 mcg/day of Folate

Dietary Supplement: Diet containing Folate

Group 2

ACTIVE COMPARATOR

Diet containing 90 mcg / day of Folate

Dietary Supplement: Diet containing Folate

Interventions

Diet containing Folate DIETARY_SUPPLEMENT

Group 1; Group 2

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 years old, with overweight or obesity
• Individuals of different socioeconomic conditions
• Users or not drugs
• Cognitive state preserved and accept participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Paraíba: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria José de Carvalho Costa, PhD

  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: May 24, 2017
• First Posted: June 14, 2017
• Study Start: August 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share