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Safety evaluation of Thai black garlic strains: a randomized controlled-placebo clinical trial in healthy volunteers

Safety evaluation of Thai black garlic strains: a randomized controlled-placebo clinical trial in healthy volunteers

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210731002
Enrollment
50
Registered
2021-07-31
Start date
2021-09-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

healthy subjects aged black garlic toxicology

Interventions

Subjects will receive 8-9 hard capsules containing placebo,Subjects will receive 8-9 hard capsules containing aged black garlic containing S-allylcysteine (SAC) 2.2mg/day
placebo,aged black garlic containing S-allylcysteine (SAC) 2.2mg/day

Sponsors

Agricultural Research Development Agency (ARDA)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Blood pressure baseline, 2 weeks, and 12 weeks mmHg,body weight and waist circumference baseline, 2 weeks, and 12 weeks kg and cm

Secondary

MeasureTime frame
Laboratory 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

Countries

Thailand

Contacts

Public ContactPornpoj Pramyothin

Mahidol University

pornpoj.pra@mahidol.edu024199322

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026