Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922491
• Other study ID #: FUParaíba1
• Status: Completed
• Phase: N/A
• First received: September 17, 2016
• Last updated: March 21, 2018
• Start date: June 1, 2016
• Est. completion date: December 10, 2016

Study information

• Verified date: February 2017
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 10, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Brazil	Rafaella Cristhine Pordeus Luna	João Pessoa	PB

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E		two months
Primary	Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E		two months