Safety evaluation of Thai black garlic strains: a randomized controlled-placebo clinical trial in healthy volunteers
- Conditions
- healthy subjectsaged black garlictoxicology
- Registration Number
- TCTR20210731002
- Lead Sponsor
- Agricultural Research Development Agency (ARDA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 50
1. aged 18-60 years old
2. BMI 18.5-22.9 kg/m2
3. waist circumference < 80 cm and < 90 cm for women and men, respectively
4. no prior medical problems
5. normal screening laboratory parameters including kidney function, liver function tests, complete blood count, coagulogram, glucose, and lipid levels
6. no antihypertensive medications and blood pressure <120/80 mmHg and >90mmHg
7. no prior history of garlic allergy
8. no dietary supplements containing garlic within 1 month of enrollment
9. no anticoagulants within 3 months of enrollment
1. history of allergy to garlic
2. has taken dietary supplements containing garlic within 1 month of enrollment
3. pregnancy and lactation
4. bleeding disorder or chronic liver disease
5. current smoking
6. alcohol use of more than 2 standard drinks/day, >5days/week
7. use of anticoagulants
8. uncontrolled psychiatric disorder
9. terminal illness
10. blood pressure of 120/80 mmHg or higher, or <90mmHg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood pressure baseline, 2 weeks, and 12 weeks mmHg,body weight and waist circumference baseline, 2 weeks, and 12 weeks kg and cm
- Secondary Outcome Measures
Name Time Method aboratory parameters baseline, 2 weeks, and 12 weeks CBC, BUN, Cr, AST, ALT, ALP, PT, aPTT, FPG, HbA1c, cholesterol, TG, HDLc, LDLc, CRP,gut microbiome analysis baseline, 2 weeks, and 12 weeks stool