Clinical Safety Study for Continuous Intake of Coffee Cherry Concentrate in Healthy Volunteers
- Conditions
- safety studyhealthy volunteersconsumerproductsafetydosemaximum toleratedbeverages and foodcoffee
- Registration Number
- TCTR20230103004
- Lead Sponsor
- MiVana Co., Ltd., Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method adverse event at 4, 8, 12 weeks after receiving interventions and at 2 weeks after stop interventions symptoms,blood biochemical parameters (CBC, liver function (AST, ALT, billirubin), kidney function (BUN, creatinine), lipid profile (cholesterol, HDL, LDL, triglycerides), fasting blood glucose (FBS) at 0, 4, 8, 12 weeks after receiving interventions and at 2 weeks after stop interventions laboratory analysis,urinalysis (protein, glucose, color, appearance, specific gravity, pH, nitrite, bilirubin, ketone, urobilinogen, blood, WBC, RBC, squamous cells, bacteria at 0, 4, 8, 12 weeks after receiving interventions and at 2 weeks after stop interventions laboratory analysis,heart function at 0, 4, 8, 12 weeks after receiving interventions and at 2 weeks after stop interventions electrocardiogram
- Secondary Outcome Measures
Name Time Method body weight at 0, 4, 8, 12 weeks after receiving interventions and at 2 weeks after stop interventions weighing scale,food intake at 0, 4, 8, 12 weeks after receiving interventions and at 2 weeks after stop interventions diet record