Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

Overview

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.

Full Title of Study: “EFFECT OF VITAMIN E SUPPLEMENTATION IN METHYLATION AND MICRORNAS PROFILE IN ADULT WOMEN WITH OVERWEIGHT”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 1, 2016

Interventions

  • Dietary Supplement: vitamin E
    • daily intake of vitamin E
  • Dietary Supplement: starch
    • daily intake of starch (control)

Arms, Groups and Cohorts

  • Experimental: Group 1
    • 400 mg Vitamin E of synthetic source 1 once daily during 2 months
  • Experimental: Group 2
    • 400 mg Vitamin E of natural source 1 once daily during 2 months
  • Placebo Comparator: Group control
    • 400 mg of starch 1 once daily during 2 months
  • No Intervention: No intervention
    • Without intervention

Clinical Trial Outcome Measures

Primary Measures

  • Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E
    • Time Frame: two months
  • Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E
    • Time Frame: two months

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federal University of Paraíba
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rafaella Cristhine Pordeus Luna, Master in nutritional sciences – Federal University of Paraíba

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