Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Isoprostane (oxidative stress)
研究概览
简要总结
This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo
详细描述
One of obesity treatments that play important role is antioxidant diet. The effects of vitamin E supplementation as an antioxidant treatment in obese adolescent have not been concluded yet in Indonesia. The primary aim of this study is to observe oxidative stress biomarker (isoprostane) in obese teenagers who consume vitamin E for 2 months. The secondary aim is to observe their body mass index and lipid profile after supplementation
The study is randomized, double blind, placebo controlled trial in design and employed a consecutive sampling technique to sample subjects of 70 obese adolescent age 14 - 18 in senior high schools Jakarta.
Blood tests of lipid profile (total cholesterol, HDL, LDL, Triglyceride), fasting blood glucose, liver function (AST,ALT) and oxidative stress biomarker (isoprostane) were taken for every subject after done fasting for 12 hours.
This study is a randomized allocation and double blind technique. subjects divided into two groups, which one group receiving treatment of vitamin E and other group receiving placebo.
The dose and duration of vitamin E treatment is 400 IU per day for 2 months. At the end of treatment, all subjects had to run the same medical interview, physical examination and blood test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity BMI ≥ p95 (CDC growth curve)
排除标准
- •Consuming antioxidants drug regularly within recruiting time
- •Consuming Orlistat
研究组 & 干预措施
Vitamin E 400 IU
Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks
干预措施: Vitamin E 400 UNT (Drug)
Placebo
Placebo capsule once per day orally for 8 weeks
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Isoprostane (oxidative stress)
时间窗: 8 weeks
pg/ml
次要结局
- Body weight(8 weeks)
- Body Height(8 weeks)
- Total Cholesterol(8 weeks)
- LDL Cholesterol(8 weeks)
- Triglycerides(8 weeks)
- BMI(8 weeks)
- HDL Cholesterol(8 weeks)
研究者
Ali Alhadar
Pediatric Fellowship at Pediatric Nutrition and Metabolic disease
Indonesia University