Pharmacokinetics of Centella Asiatica in the Elderly

NCT ID: NCT03929250

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-05
• Study Completion Date: 2024-01-03

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.

Conditions

Healthy; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

2g CAW Dose, then 4g CAW Dose

Participants first receive a single dose of a product containing 2g CAW, then after a minimum washout period of 2 weeks, they receive a single dose of a product containing 4g CAW.

Group Type: EXPERIMENTAL

2g Centella asiatica water extract product

Intervention Type: DRUG

2g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.

4g Centella asiatica water extract product

Intervention Type: DRUG

4g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.

4g CAW Dose, then 2g CAW Dose

Participants first receive a single dose of a product containing 4g CAW, then after a minimum washout period of 2 weeks, they receive a single dose of a product containing 2g CAW.

Group Type: EXPERIMENTAL

2g Centella asiatica water extract product

Intervention Type: DRUG

2g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.

4g Centella asiatica water extract product

Intervention Type: DRUG

4g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.

Interventions

2g Centella asiatica water extract product

2g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.

Intervention Type: DRUG

4g Centella asiatica water extract product

4g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.

Intervention Type: DRUG

Other Intervention Names

CAP 2g; CAP 4g

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Amala Soumyanath

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amala Soumyanath, PhD

Role: PRINCIPAL_INVESTIGATOR

OHSU Department of Neurology

Locations

Oregon Health and Science University Department of Neurology

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00017697

Identifier Type: -

Identifier Source: org_study_id