Healthy male volunteers, safety and pharmacokinetics of Mucuna pruriens seed extract Mucuna pruriens Seed extract Pharmacokinetics Clinical trial phase I Safety assessment Healthy male volunteers Dietary supplements Herbal medicine Traditional medicine Bioavailability Gastrointestinal microbiome Metabolomics Metabolite analysis Informed consent Human clinical trials Pharmacological studies Dose-response relationship Adverse effects monitoring Ethics approval
Conditions
Interventions
Group 1: A total of 14 volunteers will be administered Mucuna pruriens seed extract in capsule form, maintaining a daily dosage of 1500 mg (equivalent to L-DOPA 111.75 mg). The regimen involves admini
Experimental Drug,Active Comparator Drug
Group 1,Group 2
Sponsors
AGRICULTURAL RESEARCH DEVELOPMENT AGENCY (PUBLIC ORGANIZATION)
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male subjects of Thai nationality, aged 18-50 years. 2. Subjects with a Body Mass Index (BMI) ranging from 18.5-24.9 kg/m2 and exhibiting normal vital signs, defined as Systolic/Diastolic Blood Pressure (SBP/DBP) within 60-90/90-140 mmHg and a heart rate between 60-100 beats per minute. 3. Subjects demonstrating normal outcomes on physical examinations, encompassing evaluation of the head, eyes, ears, nose, and throat (HEENT), chest and lungs, cardiovascular system, abdomen, and extremities. 4. Laboratory evaluations falling within normal parameters, including assessments of hepatic and renal function, as well as complete blood counts (CBC). Deviations may be considered acceptable if deemed clinically insignificant by the overseeing physician. 5. Subjects must refrain from ingesting any medications, supplements, vitamins, or herbal products for a minimum of 2 weeks prior to the administration of the investigational drug, and must continue to abstain throughout the duration of the study. 6. Subjects must either be nonsmokers or restrict smoking to fewer than 10 cigarettes daily and demonstrate the ability to cease smoking for at least 1 month preceding the study and maintain this abstention throughout the duration of the study. 7. Subjects should not possess a medical history of hepatic or renal disease, nor chronic conditions such as hypertension, diabetes, or hyperlipidemia. 8. Subjects must abstain from alcohol consumption for no less than 7 days prior to receiving the investigational drug and throughout the entirety of the study. 9. Subjects must abstain from the use of illicit drugs, and their urine drug screen must return a negative result. 10. Subjects are required to provide written informed consent as a prerequisite for participation in this study.
Exclusion criteria
Exclusion criteria: 1. Participants with a history of allergies to Mucuna pruriens, plants in the legume family, or severe adverse reactions to any product used in this study, such as Stevens-Johnson syndrome, anaphylaxis, aplastic anemia, or other serious conditions that could greatly impact the participant's health. 2. Participants who receive a positive result for COVID-19 with a Rapid Antigen Test before consuming the investigational product. 3. Participants showing symptoms of illness, like headache, cough, or sore throat, before consuming the investigational product. 4. Participants who have donated blood within 3 months prior to joining the study. 5. Participants who have taken androgenic drugs (which may increase male sex hormones), medications for lowering blood sugar, levodopa, antidepressants, or foods containing L-DOPA, such as fava beans (Vicia faba Linn.) or legumes from the Cassia genus, garlic, or ginkgo biloba within 7 days before the study and are unable to stop these herbal substances for the study period. 6. Participants who have taken antibiotics, prebiotics, or probiotics within 1 month before the commencement of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic parameters at D0 before and D1 D15 D28 D31 after end of the intervention Measured at various time points using high-performance liquid chromatography (HPLC) or liquid chromatography-mass spectrometry (LC-MS).,Blood chemistry at D0 before and D1 D15 D28 D31 after end of the intervention Enzyme-Linked Immunosorbent Assay (ELISA), Electrolyte analyzers | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolome profile at D0 before and D1 D15 D28 D31 after end of the intervention Measured at various time points using high-performance liquid chromatography (HPLC) or liquid chromatography-mass spectrometry (LC-MS).,Microbiome profile at D0 before and D28 after administration 16s rRNA gene sequencing | — |
Countries
Thailand
Contacts
Public ContactKamonwan Banchuen
Department of Thai Traditional and Alternative Medicine
Outcome results
None listed