Clinical trial for identification of safety dose of coffee cherry concentrate in healthy volunteers

Phase 1

Completed

• Conditions: safety studyhealthy volunteers; consumer product safety; dose, maximum tolerated; beverages and food; coffee

• Registration Number: TCTR20220927004
• Lead Sponsor: Mivana Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-06-30
• Study Start: 2022-09-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Age 18 years old and above, 2. BMI <= 30 kg/m2, 3. healthy with normal vital signs), 4. no systemic diseases e.g. DM, obesity, liver diseases, kidney diseases, thyroid diseases, cancer, and autoimmune diseases, 5. normal blood biochemical parameters including CBC, liver function (AST, ALT, bilirubin), kidney function (BUN, creatinine), lipid profile (cholesterol, HDL, LDL, triglycerides), fasting blood glucose (FBS)

Exclusion Criteria

1. coagulation problems e.g. hemophilia, idiopathic thrombocytopenia, leukemia, 2. taking anti-coagulants e.g. warfarin, 3. pregnant or plan to be pregnant, 4. breastfeeding, 5. alcohol intake > 14 drinks per week for males or > 7 drinks per week for females and cannot refrain from alcohol intake during the study, 6. smoking > 10 cigarettes/ day, 7. allergy to coffee or caffeine, 8. anemia (Hematocrit <40% in males, < 36% in female or Hemoglobin < 13 g/ dL in males, 12 < g/ dL in females, 9. critical condition, 10. infectious diseases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adverse events for single-ascending phase every day for 14 days symptoms,adverse events for multiple-ascending phase every two weeks symptoms,blood biochemical parameters ( CBC, liver function (AST, ALT, bilirubin), kidney function (BUN, creatinine), lipid profile (cholesterol, HDL, LDL, triglycerides), fasting blood glucose (FBS) every two weeks for 12 weeks laboratory analysis

Secondary Outcome Measures

Name	Time	Method
body weight every two weeks for 12 weeks weight scale