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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220927004

Enrollment

Registered

2022-09-27

Start date

2021-06-21

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

safety study healthy volunteers consumer product safety dose, maximum tolerated beverages and food coffee

Interventions

Coffee cherry concentrate beverage was given to participants in a dose-escalation manner. There were two phases. In the single-ascending phase, six subjects received a single dose daily in a stepwise

Experimental Dietary Supplement

coffee cherry concentrate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
body weight every two weeks for 12 weeks weight scale	—

Countries

Thailand

Contacts

Public ContactDunyaporn Trachootham

Institute of Nutrition, Mahidol University

dunyaporn.tra@mahidol.edu0846953647

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026