TCTR20230103004已完成1 期
Clinical Safety Study for Continuous Intake of Coffee Cherry Concentrate in Healthy Volunteers
MiVana Co., Ltd., Thailand0 个研究点目标入组 60 人开始时间: 2023年1月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 55 Years(—)
- 性别
- All
入选标准
- •1. age 20-55 years old, 2. healthy no systemic diseases, 3. BMI <=30 kg/m2, 4. acceptable blood chemistry, i.e. hemoglobin 11-16 gm/dL for women, 12-18 g/dL for men, WBC 4,000-10,000 cells/mm3, fasting plasma glucose <=125 mg/dL, total cholesterol: HDL ratio < =5:1, ALT<=60 U/L, eGFR >= 90 mL/min/1.73 m2, 5. acceptable blood pressure and heart rate, i.e. systolic blood pressure between 90 - 140 mmHg, diastolic blood pressure between 60-90 mmHg, heart rate between 60-100 times/ min
排除标准
- •1. COVID-19-infection, 2. Allergy to coffee, caffeine, or herbal extracts, 3. Unable to follow up every 4 weeks, 4. Plan to get pregnant within 3 months, 5. Under pregnancy or breast feeding, 6. Regularly consume drugs/ herbs/ dietary supplements, 7. Drinking alcohol > 14 drinks per week for men or 7 drinks per week for women, 8. Smoking > 10 cigarettes/ day, 9. Blood clotting problems such as idiopathic thrombocytopenia, 10. Having conditions not suitable to consume caffeine-containing products such as insomnia, uncontrolled hypertension, glaucoma, severe gastritis, dyslipidemia, osteoporosis, irritable bowel syndrome, vitamin B1 deficiency, menopausal syndrome
研究者
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