Clinical trial NCT02922491: Effect of Vitamin E Supplementation in Methylation and microRNAs Profile
Official title: EFFECT OF VITAMIN E SUPPLEMENTATION IN METHYLATION AND MICRORNAS PROFILE IN ADULT WOMEN WITH OVERWEIGHT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 55
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E
timeFrame: two months
measure: Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Rafaella Cristhine Pordeus Luna
state: PB
Study officials:
References:
citation: Luna RCP, Dos Santos Nunes MK, Monteiro MGCA, da Silva CSO, do Nascimento RAF, Lima RPA, Pimenta FCF, de Oliveira NFP, Persuhn DC, de Almeida ATC, da Silva Diniz A, Pissetti CW, Vianna RPT, de Lima Ferreira FEL, Rodrigues Goncalves MDC, de Carvalho Costa MJ. alpha-Tocopherol influences glycaemic control and miR-9-3 DNA methylation in overweight and obese women under an energy-restricted diet: a randomized, double-blind, exploratory, controlled clinical trial. Nutr Metab (Lond). 2018 Jul 11;15:49. doi: 10.1186/s12986-018-0286-7. eCollection 2018.