safety study healthy volunteers consumer product safety dose maximum tolerated beverages and food coffee
Conditions
Interventions
consuming two sachets of 14 g of Coffee cherry pulp juice concentrate per day (one before breakfast and another before bedtime),consuming two sachets of 14 g of placebo drink per day (one before break
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Coffee cherry pulp juice concentrate,placebo drink
Sponsors
MiVana Co., Ltd., Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactDunyaporn Trachootham
Institute of Nutrition, Mahidol University
Outcome results
None listed