Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet containing Folate
Sponsored by

About this trial
This is an interventional prevention trial for Overweight and Obesity focused on measuring Folate, Polymorphism, Overweight and Obesity, Inflammatory markers
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Diet with 191 mcg/day of Folate
Diet containing 90 mcg / day of Folate
Outcomes
Primary Outcome Measures
Change in value of Interleukins
Change in value of homocysteine
Secondary Outcome Measures
Change in value of TNF-α
Full Information
NCT ID
NCT03186196
First Posted
May 24, 2017
Last Updated
June 12, 2017
Sponsor
Federal University of Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT03186196
Brief Title
Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers
Official Title
Influence of Polymorphism C677T MTHFR and Folate Intake in Interleukins, Homocysteine and TNF-α
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Folate, Polymorphism, Overweight and Obesity, Inflammatory markers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Diet with 191 mcg/day of Folate
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Diet containing 90 mcg / day of Folate
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet containing Folate
Primary Outcome Measure Information:
Title
Change in value of Interleukins
Time Frame
8 weeks
Title
Change in value of homocysteine
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in value of TNF-α
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Change in value of folic acid
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria José de Carvalho Costa, PhD
Organizational Affiliation
UFPB
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data of the participants are in the excel database
Learn more about this trial
Polymorphism C677T MTHFR and Folate Intake in Inflammatory Biomarkers
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