Effectiveness of IRK-19® on Body Weight Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Anthropometric measurement
研究概览
简要总结
This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract (IRK-19®) on weight management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI: 25-30 kg/m2
- •Waistline circumference: ˃ 80 cm
排除标准
- •Pregnant women or preparing for pregnancy.
- •Lactating women.
- •Women gave birth 6 months before the study.
- •Subject uses diuretic, corticosteroids, anti-depressant medications, or antipsychotic medications.
- •Subject has undertaken obesity-related surgeries within one year prior to the study or other surgeries within six months prior to the study.
- •Change of body weight of subject is over 5% within 3 months before the study.
- •Subject has serious diseases (e.g., cardiovascular diseases).
- •Cancer patient.
- •Subject has engaged in another study within 3 months before the study.
- •Subject uses another dietary supplement related to weight management during the study.
研究组 & 干预措施
Placebo
Placebo capsule
干预措施: Pumpkin seed extract (IRK-19) (Dietary Supplement)
Treatment
IRK-19 capsule
干预措施: Pumpkin seed extract (IRK-19) (Dietary Supplement)
结局指标
主要结局
Anthropometric measurement
时间窗: Week 12
Body weight
Body composition analysis
时间窗: Week 12
Body fat
Biochemistry
时间窗: Week 12
Total cholesterol
Body composition analysis
时间窗: Week 6
Body fat
Anthropometric measurement
时间窗: Week 0
Body weight
Anthropometric measurement
时间窗: Week 6
Body weight
Body composition analysis
时间窗: Week 0
Body fat
Biochemistry
时间窗: Week 0
Total cholesterol
Biochemistry
时间窗: Week 6
Total cholesterol
Biochemistry
时间窗: Weeks 12
Lectin
次要结局
未报告次要终点