Ignite Creation Date:
2024-05-06 @ 10:11 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03186196
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2017-05-24
Brief Title:
Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers
Sponsor:
Federal University of Paraíba
Organization:
Federal University of Paraíba
Study Overview
Official Title:
Influence of Polymorphism C677T MTHFR and Folate Intake in Interleukins Homocysteine and TNF-α
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2619 kg m² and 4964 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
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 2619 kg m² and 4964 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None