Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

Study Overview
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Brief Summary
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It is a study of clinical and interventional character, in which individuals who participate in the intervention will be selected for convenience of the project database entitled Second Cycle Diagnosis and Intervention Food Situation, Nutrition and Noncommunicable Disease More Prevalent Population of the city of João Pessoa / PB . They will be invited to participate in the intervention female subjects, overweight or obese, aged 20 and 59 years. The selected individuals will be distributed randomly into four groups: receive daily supplementation of 01 capsules containing 400 mg of vitamin E synthetic source (Group 1); receive daily supplementation of 01 capsules containing 400 mg of natural source vitamin E (Group 2); receive daily supplementation of 01 placebo capsule (control group); and non-intervention group. Individuals of intervention groups will receive dietary plan respecting individual needs, in order to control weight during the 08 weeks period. The subjects of the group without intervention, did not follow a diet plan, nor did they take vitamin E or placebo capsules, and were asked to continue their current eating habits over the 8-week period This project aims to evaluate whether vitamin E supplementation may modify the methylation and microRNAs profile.

Official Title
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EFFECT OF VITAMIN E SUPPLEMENTATION IN METHYLATION AND MICRORNAS PROFILE IN ADULT WOMEN WITH OVERWEIGHT

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: vitamin E
* Dietary Supplement: starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects; Persons aged between 20 and 59 years; Overweight or obese; Exclusion Criteria: Individuals consumed alcohol and / or chronic smokers; Individuals who do not have preserved cognitive status; Individuals users of multivitamins and mineral supplements, appetite suppressants and steroids; Pregnant women.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>400 mg Vitamin E of synthetic source 1 once daily during 2 months | Dietary Supplement: vitamin E<br>* daily intake of vitamin E<br>|
| Experimental: Group 2<br>400 mg Vitamin E of natural source 1 once daily during 2 months | Dietary Supplement: vitamin E<br>* daily intake of vitamin E<br>|
| Placebo Comparator: Group control<br>400 mg of starch 1 once daily during 2 months | Dietary Supplement: starch<br>* daily intake of starch (control)<br>|
| No Intervention: No intervention<br>Without intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E |  | two months | 
| Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E |  | two months |