Evaluation the Impact of Oral Dichrostachys Glomerata Extract (Dyglomera™) in Overweight and Obese Adults for Reducing Body Fat and Modulating Blood Parameters a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effect of Dyglomera on body fat of overweight and obese people
研究概览
简要总结
The extract of Dichrostachys glomerata (DyglomeraTM), has been reported to be effective in weight reduction in obese patients with metabolic syndrome. This plant has been shown to have many biological properties and has been reported to have no toxic or adverse side effects in animals. The purpose of this human study was to prove that the effect of reducing body fat percentage (%) after 12 weeks of intake was superior to that of the control group.
详细描述
This is a 12-weeks randomized double-blind placebo controlled trial. 120 number of subjects are planned. Each subject will be administered a single dose of the investigational product once daily, before lunch or dinner, consisting each time of 400 mg of the test product or placebo. Subjects will be assigned to the test group or placebo group in random order. Evaluations will be taken at baseline and at the beginning of each of the 5 study visits.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
The following investigational products will be used:
- Test product: Dichrostachys glomerata extract (Dyglomera™) at a dose of 400 mg
- Control product: Placebo at a dose of 400 mg In this human study, starting with Visit 2, the duration of participation in the human study will be 12 weeks (84 days) in total. The study period will be planned to be 8 months from the date of approval of the human study. The screening visit of the first subject will be conducted at the MAX SPECIALTY HOSPITAL, and the first subject will be enrolled thereafter. The last subject will complete the study within about 5 months.
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, Care Provider)
盲法说明
To maintain double-blinding, in addition to the contents mentioned in the production/packaging and labeling of the products used in the human study, the allocation details of unique codes (information on blinding) for each group will be managed in a sealed state by the principal investigator. Except in cases where it is unavoidably necessary to read the code due to the occurrence of a serious adverse drug reaction*, it will not be disclosed until the end of the human study. In this human study, no unblinding will occur during the study. The investigator will supply the investigational products that match the randomization code assigned to the selected subject, and maintain blinding by using an extra (by unique code) when the investigational product is defective or damaged.
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged from 19 to 65 years old,
- •Patients with a BMI ranging between 25 and 34.9 kg/m2,
- •Patients available for the entire period of study .
排除标准
- •Patients that has an age below 19 years old and greater than 65 years old,
- •Patients not available for the study period,
- •Specific exclusion criteria included: morbid obesity (BMI > 34.9 kg/m2); diabetes mellitus requiring daily insulin management; pregnancy/lactation; active infection; and systemic disease such as HIV/AIDS, active hepatitis or clinical signs of active malignancy within the past 5 years. Other exclusion criteria will include having taken any other medications or any natural health product within 1 month prior to the screening visit.
结局指标
主要结局
Effect of Dyglomera on body fat of overweight and obese people
时间窗: 12 weeks
DEXA and impedance measurement of body fat
次要结局
- Effect of Dyglomera on HDL-cholesterol levels of overweight and obese people(12 weeks)
- Effect of Dyglomera on CRP levels of overweight and obese people(12 weeks)
- Effect of Dyglomera on leptin levels of overweight and obese people(12 weeks)
- Effect of Dyglomera on blood insulin levels of overweight and obese people(12 weeks)
- Effect of Dyglomera on ALT levels of overweight and obese people(12 weeks)
- Effect of Dyglomera on blood triglyceride levels of overweight and obese people(12 weeks)
- Effect of Dyglomera on fasting blood glucose levels(12 weeks)
- Effect of Dyglomera on adiponectin levels of overweight and obese people(12 weeks)
- Effect of Dyglomera on blood cholesterol levels of overweight and obese people(12 weeks)
- Effect of Dyglomera on AST levels of overweight and obese people(12 weeks)