Black pepper extract in healthy volunteers. Effect of dietary supplement of black pepper in clinical safety.
Conditions
Interventions
To study the effect of black pepper extract supplement on the safety of liver and kidney function in normal people and on blood biochemical levels, weight, blood pressure and body mass index in normal
Experimental Dietary Supplement,Placebo Comparator No treatment
Black Pepper ,Control
Sponsors
The Agricultural Research Development Agency (Public Organization)
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Male or female, age > 18 years and legal age of consent. 2. If female, the subject is either post-menopausal or surgically sterilized, or has a negative urine kit pregnancy test within 7 days prior to enrollment and will use adequate contraception during the study. 3. Body weight >= 50 kg 4. Healthy person 5. The subject has provided written informed consent prior to admission 6. Subject can join 6 months of the entire study
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Diagnosed with diabetes mellitus 3. Chronic kidney diease with eGFR < 45 or liver disease with GOT/ PGT > 3 times ULN or total bilirubin/ direct bilirubin > 2.0/1.0 mg/dL 4. Active or uncontrolled thyroid disease 5. Status post organ transplantation 6. Immunocompromised status, including a debilitated state or malignancy 7. Frequent alcoholic consumption more than 3 times a week; with beer > 360 mL, whisky > 45 mL, wine > 150 mL for female, or beer > 720 mL, whisky > 90 mL, wine > 300 mL for male each time 8. Has history of cancer within 5 years or congestive heart failure stage 3-4 9. Has gastrointestinal symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation 10. Lack of ability or willingness to give informed consent 11. Has cardiovascular or cerebrovascular disease 12. Enrolled in any other clinical study within 12 weeks before enrollment 13. Has other disease that do not appropriate to join the study by investigator judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver and renal toxicity week -1,week 0+-5 day,end of week 2+-5 day,end of week 4+-5 day,end of week 12+-5 day,end of week 16+-5 day Close out Blood test in volunteers was performed to determine the maximum immunogenic dose of PFPE extract without liver and kidney toxicity (HED, mg/kg) total 43 x (6/37) total 6.97 mg/kg body weight/day. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effects of black pepper extract on blood biochemical levels, body weight, blood pressure, and body mass index week -1,week 0+-5 day,end of week 2+-5 day,end of week 4+-5 day,end of week 12+-5 day,end of week 16+-5 day Close out Weighing, height measurement, blood pressure measurement, pulse measurement, body mass index measurement, and general physical examination, including blood biochemistry laboratory tests. | — |
Countries
Thailand
Contacts
Public ContactSupawan Buranapin
Faculty of medicine, Chiang Mai University
Outcome results
None listed