EFFECT OF VITAMIN E SUPPLEMENTATION IN METHYLATION AND MICRORNAS PROFILE IN ADULT WOMEN WITH OVERWEIGHT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 59 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects;
- •Persons aged between 20 and 59 years;
- •Overweight or obese;
排除标准
- •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.
研究组 & 干预措施
Group 2
400 mg Vitamin E of natural source
1 once daily during 2 months
干预措施: vitamin E (Dietary Supplement)
Group 1
400 mg Vitamin E of synthetic source
1 once daily during 2 months
干预措施: vitamin E (Dietary Supplement)
Group control
400 mg of starch
1 once daily during 2 months
干预措施: starch (Dietary Supplement)
No intervention
Without intervention
结局指标
主要结局
Comparison of methylation profile of DNA in overweight and obese women before and then intervention with vitamin E
时间窗: two months
Comparison of microRNAs profile in overweight and obese women before and then intervention with vitamin E
时间窗: two months
次要结局
未报告次要终点
研究者
Rafaella Cristhine Pordeus Luna
Master in nutritional sciences
Federal University of Paraíba
