Safety and effect of black garlic administration on antioxidant capacity and lipid profile in healthy volunteers

Phase 2

Completed

• Conditions: Healthy volunteers; black garlic ,antioxidant capacity ,lipid profile

• Registration Number: TCTR20240619002
• Lead Sponsor: Agricultural Research Development Agency (public organization)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-04-30
• Study Start: 2024-06-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1) Volunteers of both genders
2) Aged between 20-45 years
3) Body Mass Index (BMI) between 18 and 25 kg/m2
4) Individuals in good health (without chronic conditions such as abnormal blood lipids, diabetes, high blood pressure, heart and vascular disease, liver disease, kidney disease, hormonal disorders, blood disorders, or no hospitalization and physician visits in the past 6 months)
5) Not pregnant, planning pregnancy, or breastfeeding
6) LDL-C levels not exceeding 189 mg/dL for those aged 20-34 years and not exceeding 130 mg/dL for those aged 35-45 years
7) No elevated liver enzymes (greater than 2 times the upper limit of normal) and no impaired kidney function (glomerular filtration rate; GFR less than 60 ml/min/1.73 m2)
8) Willing to abstain from smoking, alcohol consumption, or any medication (except pain relievers such as paracetamol or contraceptives), including herbal supplements or vitamins, within 7 days before the study until its completion.
9) Able to communicate effectively
10) Willing and able to comply with the study requirements.

Exclusion Criteria

1) Taking anticoagulants or antiplatelet drugs such as warfarin, aspirin, and coumarin.
2) Previously diagnosed or treated with lipid-lowering medications.
3) Medical history related to clinically significant health abnormalities or physical examinations showing health abnormalities that the physician deems unsuitable for participation in the study.
4) History of severe allergic reactions (anaphylaxis), hypersensitivity reactions, or clinically significant reactions to any herbal supplements.
5) History of garlic or black garlic allergies.
6) History of acute infections within the past 1 month before the study.
7) Consuming immunostimulant drugs or non-steroidal anti-inflammatory drugs (NSAIDs).
8) Previously taken medications or participated in another study related to drugs or medical devices within 30 days before joining this study.
9) History of substance abuse within the past 6 months before participating in this study.
10) Risk factors for bleeding, such as undergoing major surgery within the past 6 months or uncontrolled high blood pressure.
11) Taking weight-loss medications within the past 6 months.
12) Engaging in regular intense physical activity.
13) Strictly controlling diet.
14) Not willing to use medically acceptable birth control methods during participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vital signs monitoring and body measurements 12 weeks Thermometers, blood pressure and heart rate monitors, stethoscopes, personal scales, soft metric tape, and In body scan machines,Clinical laboratory testing: (CBC, FBS, LFT and RFT). 12 weeks Lab investigation,Blood lipid level analysis (Lipid profile): (Chol, LDL-C, HDL-C, TG) 12 weeks Lab investigation,Assessment of antioxidant capacity and oxidative stress: (Serum TAC & MDA) 12 weeks Lab investigation

Secondary Outcome Measures

Name	Time	Method
Inquire about side effects and adverse events resulting from the use of black garlic products. 8 weeks Interview-based inquiry