Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922491
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Rafaella Cristhine Pordeus Luna, 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: vitamin E Dietary Supplement: starch Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: EFFECT OF VITAMIN E SUPPLEMENTATION IN METHYLATION AND MICRORNAS PROFILE IN ADULT WOMEN WITH OVERWEIGHT
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : November 1, 2016
Actual Study Completion Date : December 10, 2016


Arm Intervention/treatment
Experimental: Group 1

400 mg Vitamin E of synthetic source

1 once daily during 2 months

Dietary Supplement: vitamin E
daily intake of vitamin E

Experimental: Group 2

400 mg Vitamin E of natural source

1 once daily during 2 months

Dietary Supplement: vitamin E
daily intake of vitamin E

Placebo Comparator: Group control

400 mg of starch

1 once daily during 2 months

Dietary Supplement: starch
daily intake of starch (control)

No Intervention: No intervention
Without intervention



Primary Outcome Measures :
  1. Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E [ Time Frame: two months ]
  2. Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E [ Time Frame: two months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922491


Locations
Layout table for location information
Brazil
Rafaella Cristhine Pordeus Luna
João Pessoa, PB, Brazil, 58051900
Sponsors and Collaborators
Federal University of Paraíba

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rafaella Cristhine Pordeus Luna, Master in nutritional sciences, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT02922491    
Other Study ID Numbers: FUParaíba1
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents