- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03186196
Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers
Influence of Polymorphism C677T MTHFR and Folate Intake in Interleukins, Homocysteine and TNF-α
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
Diet with 191 mcg/day of Folate
|
|
ACTIVE_COMPARATOR: Group 2
Diet containing 90 mcg / day of Folate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in value of Interleukins
Time Frame: 8 weeks
|
8 weeks
|
Change in value of homocysteine
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in value of TNF-α
Time Frame: 8 weeks
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in value of folic acid
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maria José de Carvalho Costa, PhD, UFPB
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUParaíbaaa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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