Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

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

Sponsors

Lead Sponsor: Federal University of Paraíba

Source 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.

Overall Status Completed
Start Date June 1, 2016
Completion Date December 10, 2016
Primary Completion Date November 1, 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 55
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: vitamin E

Description: daily intake of vitamin E

Intervention Type: Dietary Supplement

Intervention Name: starch

Description: daily intake of starch (control)

Arm Group Label: Group control

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.

Gender: Female

Minimum Age: 20 Years

Maximum Age: 59 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Rafaella Cristhine Pordeus Luna
Location Countries

Brazil

Verification Date

February 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Federal University of Paraíba

Investigator Full Name: Rafaella Cristhine Pordeus Luna

Investigator Title: Master in nutritional sciences

Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Group 1

Type: Experimental

Description: 400 mg Vitamin E of synthetic source 1 once daily during 2 months

Label: Group 2

Type: Experimental

Description: 400 mg Vitamin E of natural source 1 once daily during 2 months

Label: Group control

Type: Placebo Comparator

Description: 400 mg of starch 1 once daily during 2 months

Label: No intervention

Type: No Intervention

Description: Without intervention

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Screening

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov