The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change from baseline fat mass at 12-week.
研究概览
简要总结
It is well known that steam onion have benefit effects on controlling the blood sugar, triacylglycerol (TG) and total cholesterol (TC). In this study, the jeju steam onion examined whether it has beneficial effects on reducing body fat of overweight or obesity subjects.
详细描述
A randomized, double-blind, placebo-controlled clinical trial was conducted to verify the effects of jeju steam onion. Fifty-six healthy male and female subjects aged 20-65 years with normal body weight [25.0 kg/㎡ ≤ body mass index (BMI) < 30.0 kg/㎡] were recruited. The basic framework of the present study was based on a previous study. A 12-week (at each visit; screening, 6-week, 12-week), placebo-controlled, randomized study was conducted with overweight subjects (25.0 kg/㎡ ≤ BMI < 30 kg/㎡). Subjects participants were divided into two group: either Jeju steaming onion or matching placebo (the baked barley powder). Randomization was achieved by computer generated block randomization (placebo : test = 1 : 1).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight(WHO) subjects [25.0 kg/㎡ ≤ body mass index (BMI) < 30 kg/㎡]
排除标准
- •uncontrolled blood pressure (blood pressure level more than 140/100mmHg)
- •fasting blood sugar level more than 126 mg/dl or taking medications (including blood sugar and anti-diabetic drugs)
- •history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
- •taking a weight change medications within 1 month before study
- •participation other obese studies within 2 months before study
- •having a known allergy to any ingredient in the investigational product
- •participation other intervention studies within 1 months before study
- •women who are pregnant or desire to become pregnant during the study period
- •having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study
研究组 & 干预措施
baked barley powder consumption
Subjects randomized to the placebo group received one tablet containing baked barley powder per day (900 mg/day). placebo group consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.
干预措施: baked barley powder (Dietary Supplement)
jeju steam onion powder consumption
Subjects randomized to the test group received one tablet containing jeju steam onion powder per day (900 mg/day). placebo group consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.
干预措施: jeju steam onion (Dietary Supplement)
结局指标
主要结局
Change from baseline fat mass at 12-week.
时间窗: at baseline and 12-week follow-up
The body composition of the study participants was measured via dual-energy X-ray absorptiometry (DEXA) to determine
次要结局
- Change from baseline lean body mass at 12-week.(at baseline and 12-week follow-up)
- Change from baseline fat percentage at 12-week.(at baseline and 12-week follow-up)
- Change from baseline subcutaneous fat area of L1 and L4 at 12-week.(at baseline and 12-week follow-up)
- Change from baseline visceral/subcutaneous fat area ratio of L1 and L4 at 12-week.(at baseline and 12-week follow-up)
- Change from baseline whole fat area of L1 and L4 at 12-week.(at baseline and 12-week follow-up)
- Change from baseline visceral fat area of L1 and L4 at 12-week.(at baseline and 12-week follow-up)
研究者
Jong Ho Lee
Professor, PI
Yonsei University