NCT03186196

Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers

Completed NA Last updated 14 June 2017

What this trial tests

NA trial testing Diet containing Folate in Overweight and Obesity in 48 participants. Completed in 1 May 2017.

Timeline

1 August 2016

Primary endpoint
1 December 2016

1 May 2017

Quick facts

Lead sponsor	Federal University of Paraíba
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	48
Start date	1 August 2016
Primary completion	1 December 2016
Estimated completion	1 May 2017

Drugs / interventions tested

• Diet containing Folate

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Federal University of Paraíba

Who can join

Adults 20 to 59, female only, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Food Intervention with Folate Reduces TNF-α and Interleukin Levels in Overweight and Obese Women with the <i>MTHFR</i> C677T Polymorphism: A Randomized Trial.
   Lisboa JVC, Ribeiro MR, Luna RCP, Lima RPA, et al · · 2020 · cited 21× · PMID 32019154 · DOI 10.3390/nu12020361