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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02922491
Enrollment
55
Registered
2016-10-04
Start date
2016-06-01
Completion date
2016-12-10
Last updated
2018-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

DIETARY_SUPPLEMENTvitamin E

daily intake of vitamin E

DIETARY_SUPPLEMENTstarch

daily intake of starch (control)

Sponsors

Federal University of Paraíba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 59 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin Etwo months
Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin Etwo months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026