A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect of Heat-Treated Green Tea Extract Complex
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of body fat by DEXA
研究概览
简要总结
This clinical study was designed to evaluate the efficacy and safety of body fat reduction in obese adults by treatment of heat-treated green tea extract complex
详细描述
This study is a 12-week, randomized, double-blind, placebo-controlled clinical trial. 100 subjects were ranromly assigned to heat-treated green tea extract(HTGT) group and placebo group. The changes in the efficacy endpoint were evaluated after treatment of 2 capsules of HTGT once daiy for 12 weeks.
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
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •lt;Inclusion Criteria>
- •Males and females aged between 19 ~ 64 years
- •BMI 25.0 ~ 34.9 kg/m^2
- •Waist circumferebce: 90cm or more for men, 85cm or more for women
- •Subjects who have fully understand the information provided about the study and voluntarily decided to participate
排除标准
- •Participants whose weight changed by more than 10% within the 3 months prior to visit 1
- •Individuals participated in a commercial weight loss program within 3 months prior to Visit 1
- •Participants who have undergone surgical procedures within 3 years
- •Participants who have taken obesity treatment medications within the last 3 months
- •Individuals who have taken medications affecting weight or dietary supplements for weight control within the last month
- •Subjects with uncontrolled hypertension
- •Subjects diagnosed with diabetes
- •TSH <0.1 uIU/ml or >10 uIU/ml
- •Creatinine >1.5mg/dL
- •AST or ALT > three times the upper normal limit
研究组 & 干预措施
HTGT compound
-
Dietary supplement: HTGT compound
-
oral administration of HTGT compound once daily, 2 capsules per day.
-
Dietary supplement; Placebo
-
oral administration of placebo once daily, 2 canpules per day
干预措施: HTGT compound (Dietary Supplement)
Placebo
Once daily, 2 capsules per day
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change of body fat by DEXA
时间窗: Baseline, Week 12
Measurement was made by using dual-energy X-ray absorption(DEXA)
次要结局
- Changes of total abdominal fat area, visceral fat area and subcutaneous fat area(Baseline, Week 12)
- Changes of indicator of lipid metabolism(Baseline, Week 12)
- Changes of waist circumference(Baseline, Week 12)
- Changes of blood biomarker(Baseline, Week 12)