Clinical trial NCT03929250: Pharmacokinetics of Centella Asiatica in the Elderly
Official title: A Pharmacokinetic Study of Centella Asiatica in the Elderly
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Healthy
Elderly
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 8
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomization will use an arm equivalence design to promote equal numbers of participants for each order schema.
Primary purpose: SCREENING

Brief summary: This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract (CAW) product (CAP) in cognitively healthy elders.

Detailed description: PRIMARY OBJECTIVES:

1. To assess the bioavailability and rate of clearance of Centella asiatica derived compounds in the plasma and urine of cognitively healthy elders over 12 hours.
2. To determine the acute tolerability of a Centella asiatica product in cognitively healthy elders.

OUTLINE:

Participants will orally consume a single administration of a standardized Centella asiatica water extract product (CAP). Two doses (2g and 4g CAW) will be administered on separate occasions, at least two weeks apart. The levels of known bioactive compounds present in Centella asiatica will be measured in human plasma and urine over 12 hours after administration of each of the doses.

Eligibility criteria: Inclusion Criteria:

1. Age 65-85, male and female
2. Sufficient English language skills to complete all tests
3. Sufficient vision and hearing to complete all tests
4. No known allergies to Centella asiatica or CAP components
5. Willingness to discontinue all botanical dietary supplements for one week prior to and during each study visit
6. Willingness to comply with a 48-hour low plant diet for each study visit
7. Absence of significant depression symptoms (Geriatric Depression Scale-15 score of \<12)
8. Body Mass Index (BMI) greater than 17 and less than 35 at screening
9. Non-demented, defined as Clinical Dementia Rating (CDR) score of zero and Mini Mental State Examination (MMSE) score \>28
10. General health status that will not interfere with the ability to complete the study

Exclusion Criteria:

1. Current smoking, alcohol or substance abuse according to DSM-V criteria
2. Women who are pregnant, planning to become pregnant or breastfeeding
3. Men who are actively trying to conceive a child or planning to within three months of study completion
4. Severe aversion to venipuncture
5. Abnormal laboratory evaluation indicating asymptomatic and untreated urinary tract infection
6. Cancer within the last five years, with the exception of localized prostate cancer (Gleason Grade \<3) and non-metastatic skin cancers
7. Comorbid conditions such as diabetes mellitus, kidney failure, liver failure, hepatitis, blood disorders, clinical symptomatic orthostatic hypotension, and unstable or significantly symptomatic cardiovascular disease
8. Significant disease of the central nervous system such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke
9. Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-V criteria
10. Medications: sedatives (except those used occasionally for sleep), central nervous system active medications that have not been stable for two months (including beta blockers, cimetidine, SSRIs, SNRIs), anticoagulants (i.e. Warfarin), investigational drugs used within five half-lives of baseline visit, systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, narcotic analgesics, nicotine (tobacco, patches, gum, lozenges, etc.), Cannabis sativa (herb or edibles)
11. Diseases associated with dementia such as Alzheimer's disease, vascular dementia, normal pressure hydrocephalus or Parkinson's disease with a CDR score \>0.5 and MMSE score \<28
12. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

Primary outcomes:
measure: Human plasma concentration of bioactives from Centella asiatica.
timeFrame: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).
Secondary outcomes:
measure: Time of maximum concentration
timeFrame: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).
measure: Temporal changes in anti-oxidant status
timeFrame: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).
measure: Urinary excretion
timeFrame: Over 12 hours post-administration
measure: Half-life
timeFrame: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).
measure: Oral temperature
timeFrame: 0, 360 and 720 minutes after administration
measure: Pulse rate
timeFrame: 0, 360 and 720 minutes after administration
measure: Seated blood pressure
timeFrame: 0, 360 and 720 minutes after administration
measure: Body mass index
timeFrame: 0, 360 and 720 minutes after administration
measure: Electrocardiography
timeFrame: 0, 360 and 720 minutes after administration
measure: Liver function
timeFrame: 0, 360 and 720 minutes after administration
measure: Kidney function
timeFrame: 0, 360 and 720 minutes after administration
measure: Adverse events
timeFrame: 0, 6, 12 and 24 hours after administration
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University Department of Neurology
state: Oregon
Study officials:
affiliation: OHSU Department of Neurology
name: Amala Soumyanath, PhD
role: PRINCIPAL_INVESTIGATOR
References: