Pharmacokinetics of Centella Asiatica in the Elderly

NCT03929250 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: STUDY00017697
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Elderly

Outcome Measures

Primary Outcomes (4)

• Maximum Human Plasma Concentration of Bioactives From Centella Asiatica.

  Following oral administration of a product made from a water extract of Centella asiatica (CAP), the plasma concentration of Centella asiatica derived bioactive compounds (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in blood samples obtained over a 12 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration and area under the curve) for each of the two doses (2g and 4g).

  A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).

• Total Plasma Concentration Over Time (Area Under the Curve) From Centella Asiatica Water Extract Product.

  Following oral administration of a product made from a water extract of Centella asiatica (CAP), the plasma concentration of Centella asiatica derived bioactive compounds (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in blood samples obtained over a 12 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration and area under the curve) for each of the two doses (2g and 4g).

  A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).

• Half-life

  The half-life (t1/2) of the known bioactive compounds was calculated from the plasma concentrations measured by high performance liquid chromatography tandem mass spectrometry to help determine dosage intervals.

  A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).

• Time of Maximum Concentration

  The time of maximum concentration (tmax) of the known bioactive compounds and their metabolites will be calculated from the concentrations measured by high performance liquid chromatography tandem mass spectrometry in order to help determine dosage intervals

  A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).

Secondary Outcomes (7)

• Urinary Excretion

  Over 12 hours post-administration

• Oral Temperature

  720 minutes after administration

• Pulse Rate

  720 minutes after administration

• Seated Systolic Blood Pressure

  720 minutes after administration

• Body Mass Index

  720 minutes after administration

Study Arms (2)

2g CAW Dose, then 4g CAW Dose

EXPERIMENTAL

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.

Drug: 2g Centella asiatica water extract product; Drug: 4g Centella asiatica water extract product

4g CAW Dose, then 2g CAW Dose

EXPERIMENTAL

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.

Drug: 2g Centella asiatica water extract product; Drug: 4g Centella asiatica water extract product

Interventions

2g Centella asiatica water extract product 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.

Also known as: CAP 2g

2g CAW Dose, then 4g CAW Dose; 4g CAW Dose, then 2g CAW Dose

4g Centella asiatica water extract product 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.

Also known as: CAP 4g

2g CAW Dose, then 4g CAW Dose; 4g CAW Dose, then 2g CAW Dose

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current smoking, alcohol or substance abuse according to DSM-V criteria
• Women who are pregnant, planning to become pregnant or breastfeeding
• Men who are actively trying to conceive a child or planning to within three months of study completion
• Severe aversion to venipuncture
• Abnormal laboratory evaluation indicating asymptomatic and untreated urinary tract infection
• Cancer within the last five years, with the exception of localized prostate cancer (Gleason Grade \<3) and non-metastatic skin cancers
• Comorbid conditions such as diabetes mellitus, kidney failure, liver failure, hepatitis, blood disorders, clinical symptomatic orthostatic hypotension, and unstable or significantly symptomatic cardiovascular disease
• Significant disease of the central nervous system such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke
• Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-V criteria
• 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)
• 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
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University Department of Neurology

Portland, Oregon, 97239, United States

Location

Results Point of Contact

• Title: Dr. Amala Soumyanath
• Organization: Oregon Health & Science University

soumyana@ohsu.edu

503-494-6878

Study Officials

• Amala Soumyanath, PhD

  OHSU Department of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization will use an arm equivalence design to promote equal numbers of participants for each order schema.

Study Record Dates

• First Submitted: April 21, 2019
• First Posted: April 26, 2019
• Study Start: July 5, 2019
• Primary Completion: November 30, 2019
• Study Completion: January 3, 2024
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Immediately after publication and for a period of 3 years following publication.
• Access Criteria: Anyone who wishes access to the data, for any reason. Requests should be directed to Dr Amala Soumyanath at soumyana@ohsu.edu

Locations

US (1)