A study on safety and effect of black garlic administration on antioxidant capacity and lipid profile in healthy volunteers

Agricultural Research Development Agency (public organization)0 个研究点目标入组 35 人开始时间: 2024年6月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•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.

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