Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: starch; Dietary Supplement: vitamin E

• Registration Number: NCT02922491
• Lead Sponsor: Federal University of Paraíba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-09-17
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Primary Completion: 2016-11-01
• Study Completion: 2016-12-10
• Status Verified: 2017-02
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group control	starch	400 mg of starch 1 once daily during 2 months
Group 1	vitamin E	400 mg Vitamin E of synthetic source 1 once daily during 2 months
Group 2	vitamin E	400 mg Vitamin E of natural source 1 once daily during 2 months

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rafaella Cristhine Pordeus Luna; 🇧🇷 João Pessoa, PB, Brazil