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临床试验/NCT02922491
NCT02922491已完成不适用

EFFECT OF VITAMIN E SUPPLEMENTATION IN METHYLATION AND MICRORNAS PROFILE IN ADULT WOMEN WITH OVERWEIGHT

Federal University of Paraíba1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

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

Experimental

400 mg Vitamin E of natural source

1 once daily during 2 months

干预措施: vitamin E (Dietary Supplement)

Group 1

Experimental

400 mg Vitamin E of synthetic source

1 once daily during 2 months

干预措施: vitamin E (Dietary Supplement)

Group control

Placebo Comparator

400 mg of starch

1 once daily during 2 months

干预措施: starch (Dietary Supplement)

No intervention

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

发起方
Federal University of Paraíba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rafaella Cristhine Pordeus Luna

Master in nutritional sciences

Federal University of Paraíba

研究点 (1)

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