Ashwagandha Pharmacokinetics Study in Older Adults

Inclusion Criteria:

1. Age 65 and older, male and female

2. Body Mass Index (BMI) greater than 17 and less than 35 at screening

3. Sufficient vision and hearing to complete all tests

4. Willingness to discontinue all botanical supplementation for one week prior to andthroughout study

5. No known sensitivity to Withania somnifera or any of its derivatives

6. Normal or clinically not significant 12-lead electrocardiogram (ECG) recording

7. Hepatic (ALT, AST, bilirubin), renal (creatinine, estimated GFR), and TSH parameterswithin normal range

8. Hemoglobin ≥13.0 g/dL or hematocrit ≥39% (males) OR hemoglobin ≥12.5 g/dL orhematocrit ≥38% (females), per FDA recommendations on blood donation

9. General health status that will not interfere with the ability to complete the study

10. Willingness to attend all study visits

11. Willingness to avoid caffeine and xanthine-containing foods or beverages (e.g.,coffee, tea, chocolate, caffeine-containing sodas, colas, etc.), as well asgrapefruit juice and poppy-containing foods for 48 hours prior to baseline visits

12. Willingness to adhere to special diet (no dairy, grapefruit products,poppy-containing foods, high-fat meals, caffeine, or xanthine-containing foods orbeverages) during baseline visits and until after 24-hour visit

13. Mini-Mental State Exam (MMSE) score ≥26

Exclusion Criteria:

1. Current smoking, alcohol, or substance abuse according to DSM-V criteria

2. Participants who are currently pregnant, actively trying to conceive a child, orplanning to within three months of study completion

3. Severe aversion to venipuncture

4. Donation of blood within 90 days of screening

5. Participation in drug research study within 90 days of screening

6. Serious health condition (i.e., illness, injury, impairment, or physical or mentalcondition which requires a) overnight hospitalization or b) continuing treatmentthat may cause episodic periods of incapacity of more than 3 consecutive days)within 30 days of screening

7. Allergy to nightshade plants (Solanaceae family)

8. Abnormal labs indicating symptomatic and untreated urinary tract infection

9. History of prostate cancer

10. History of kidney transplant

11. Cancer within the last five years, with the exception of non-metastatic skin cancers

12. Comorbid conditions requiring medication such as diabetes, kidney failure, liverfailure, hepatitis, blood disorders, hypotension, thyroid disease, respiratorydisorders, or cardiovascular disease

13. Presence of sleep apnea, moderate to severe restless leg syndrome, major circadianrhythm changes, or narcolepsy

14. Significant disease of the Central Nervous System (CNS) such as brain tumor, seizuredisorder, subdural hematoma, cranial arteritis, or clinically significant stroke

15. Diagnosis of major depression, schizophrenia, bipolar disorder, or other majorpsychiatric disorder as defined by DSM-V criteria

16. Diseases associated with dementia such as Alzheimer's disease, vascular dementia,normal pressure hydrocephalus or Parkinson's disease