Skip to main content
OpenTrials
Completed

NCT Number: NCT02922491

Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rafaella Cristhine Pordeus Luna

João Pessoa, Paraíba, 58051900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin E

Dietary Supplement

daily intake of vitamin E

starch

Dietary Supplement

daily intake of starch (control)

Primary outcomes

  1. Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E

    Time frame: two months

  2. Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E

    Time frame: two months

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 4, 2016
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.