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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: vitamin E; Dietary supplement: starch

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PB
    • João Pessoa, PB, Brazil, 58051900
      • Rafaella Cristhine Pordeus Luna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Paraíba

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 10, 2016

Study Registration Dates

• First Submitted: September 17, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E
• Other Study ID Numbers: FUParaíba1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No