A Pharmacokinetic Study of Centella Asiatica in the Elderly
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum Human Plasma Concentration of Bioactives From Centella Asiatica.
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVES:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 2g Centella asiatica water extract product (Drug)
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.
干预措施: 4g Centella asiatica water extract product (Drug)
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.
干预措施: 2g Centella asiatica water extract product (Drug)
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.
干预措施: 4g Centella asiatica water extract product (Drug)
结局指标
主要结局
Maximum Human Plasma Concentration of Bioactives From Centella Asiatica.
时间窗: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).
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).
Half-life
时间窗: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).
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.
Total Plasma Concentration Over Time (Area Under the Curve) From Centella Asiatica Water Extract Product.
时间窗: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).
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).
Time of Maximum Concentration
时间窗: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).
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
次要结局
- Pulse Rate(720 minutes after administration)
- Seated Diastolic Blood Pressure(720 minutes after administration)
- Urinary Excretion(Over 12 hours post-administration)
- Seated Systolic Blood Pressure(720 minutes after administration)
- Oral Temperature(720 minutes after administration)
- Body Mass Index(720 minutes after administration)
- Participants With Change in Electrocardiography(0, 360 and 720 minutes after administration)
研究者
Amala Soumyanath
Professor
Oregon Health and Science University