- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02953522
Polymorphism C677T MTHFR and Effects of Folate Intake
Polymorphism C677T MTHFR and Diet With Folate in Oxidative Stress, Lipid Profile and Homocysteine
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 home visits and the questionnaires related to anthropometric and food intake assessment were conducted by teams of undergraduate researchers and graduates of Nutrition Course, masters and doctoral students of the Post Graduate Program in Nutrition Sciences (PPGCN) of UFPB 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, sound overweight or obese
- Individuals of different socioeconomic conditions
- Users or not drugs
- Cognitive state preserved and accept participate
Exclusion Criteria:
- Drinkers, smokers or 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 |
---|---|
OTHER: 191 mcg/day of Folate
Diet with 191 mcg/day of Folate
|
Diet containing 191 mcg / day of Folate
|
OTHER: 90 mcg/day of Folate
Diet with 90 mcg/day of Folate
|
Diet containing 90 mcg / day of Folate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in value of total antioxidant capacity
Time Frame: 8 weeks
|
Change in value of total antioxidant capacity
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUParaíbaa
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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