Effect of Vitamin E Supplementation in Methylation and microRNAs Profile

Federal University of Paraíba

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: vitamin E; Dietary Supplement: starch

Study type: Interventional

Funder types: Other

Identifiers

NCT02922491

FUParaíba1

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

55 participants in 4 patient groups, including a placebo group

Group 1

Experimental group

Description:

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

Treatment:

Dietary Supplement: vitamin E

Group 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: vitamin E

Group control

Placebo Comparator group

Description:

400 mg of starch 1 once daily during 2 months

Treatment:

Dietary Supplement: starch

No intervention

No Intervention group

Description:

Without intervention