Ashwagandha Pharmacokinetics Study in Older Adults

Stopped early · Early Phase 1

Conditions studied: Healthy, Aging

In brief

This study will measure the oral bioavailability and pharmacokinetics of known compounds from a standardized Withania somnifera botanical dietary supplement in healthy older adults.

Key facts

Study ID

NCT06171724

Run by

Oregon Health and Science University

People needed

11

Starts

2024-04-08

Expected to finish

2024-12-09

Last updated by the study team

2026-04-09

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 65 and older, male and female
• Body Mass Index (BMI) greater than 17 and less than 35 at screening
• Sufficient vision and hearing to complete all tests
• Willingness to discontinue all botanical supplementation for one week prior to and throughout study
• No known sensitivity to Withania somnifera or any of its derivatives
• Normal or clinically not significant 12-lead electrocardiogram (ECG) recording
• Hepatic (ALT, AST, bilirubin), renal (creatinine, estimated GFR), and TSH parameters within normal range
• Hemoglobin ≥13.0 g/dL or hematocrit ≥39% (males) OR hemoglobin ≥12.5 g/dL or hematocrit ≥38% (females), per FDA recommendations on blood donation
• General health status that will not interfere with the ability to complete the study
• Willingness to attend all study visits
• Willingness to avoid caffeine and xanthine-containing foods or beverages (e.g., coffee, tea, chocolate, caffeine-containing sodas, colas, etc.), as well as grapefruit juice and poppy-containing foods for 48 hours prior to baseline visits
• Willingness to adhere to special diet (no dairy, grapefruit products, poppy-containing foods, high-fat meals, caffeine, or xanthine-containing foods or beverages) during baseline visits and until after 24-hour visit
• Mini-Mental State Exam (MMSE) score ≥26

You may not qualify if…

• Current smoking, alcohol, or substance abuse according to DSM-V criteria
• Participants who are currently pregnant, actively trying to conceive a child, or planning to within three months of study completion
• Severe aversion to venipuncture
• Donation of blood within 90 days of screening
• Participation in drug research study within 90 days of screening
• Serious health condition (i.e., illness, injury, impairment, or physical or mental condition which requires a) overnight hospitalization or b) continuing treatment that may cause episodic periods of incapacity of more than 3 consecutive days) within 30 days of screening
• Allergy to nightshade plants (Solanaceae family)
• Abnormal labs indicating symptomatic and untreated urinary tract infection
• History of prostate cancer
• History of kidney transplant
• Cancer within the last five years, with the exception of non-metastatic skin cancers
• Comorbid conditions requiring medication such as diabetes, kidney failure, liver failure, hepatitis, blood disorders, hypotension, thyroid disease, respiratory disorders, or cardiovascular disease
• Presence of sleep apnea, moderate to severe restless leg syndrome, major circadian rhythm changes, or narcolepsy
• Significant disease of the Central Nervous System (CNS) such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke
• Diagnosis of major depression, schizophrenia, bipolar disorder, or other major psychiatric disorder as defined by DSM-V criteria
• Diseases associated with dementia such as Alzheimer's disease, vascular dementia, normal pressure hydrocephalus or Parkinson's disease

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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