Centella Asiatica in Older Adults

Effect of Centella Asiatica on Vascular Endothelial Function in Older Adults

The purpose of this study is to determine the effects of a dietary supplement containing centella asiatica on on vascular endothelial function in older adults.

Study Overview

• Status: Not yet recruiting
• Conditions: Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: Centella Asiatica; Dietary supplement: Placebo Comparator

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Gundersen, MS; Phone Number: 503-552-1752; Email: agundersen@nunm.edu
• Study Contact Backup: Name: Benjamin Zimmerman, PhD; Phone Number: 503-502-1862; Email: bzimmerman@nunm.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • Helfgott Research Institute
      • Contact: Anders Gundersen, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

● Age 50 through 85, male or female

• Sufficient proficiency in English to understand study purpose and directions
• Willing and able to give informed consent
• Able to follow protocol and attend visits

Exclusion Criteria:

• History of myocardial infarction, known coronary or carotid disease, or heart failure
• History of stroke, Parkinson's disease, dementia, or other major CNS disorders
• History of hepatic disease (e.g. hepatitis, cirrhosis)
• Recent/recurring history of severe life-threatening medical conditions (e.g. cancer, except non-melanoma skin cancers)
• Active major infectious disease (e.g. pneumonia)
• Heavy alcohol use (15 drinks or more per week for men or 8 drinks or more per week for women) or substance use disorder
• Current use of any medication typically used to treat hypertension or lower blood pressure (e.g. beta-blockers, ACE inhibitors)
• Current use of any medication typically used to prevent the coagulation of blood (e.g. warfarin (Coumadin))
• Chronic NSAID use (>3 times a week for more than 3 months)
• Current use of any medication or supplement typically used as a sedative (e.g. zolpidem (Ambien), benzodiazepines (Valium, Xanax), valerian root)
• Dietary supplements for improving nitric-oxide synthesis (e.g. L-arginine, L-citrulline)
• Current use of any medication typically used to control hypoglycemia (e.g. biguanides (Metformin))
• Current use of any medication typically used for erectile dysfunction (e.g. sildenafil (Viagra), tadalafil (Cialis))
• Pregnant, nursing, or planning a pregnancy within the next 6 weeks
• Open skin rashes and sores that may interfere with the placement of sensors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Centlla Asiatica; 250 mg/day (1 capsules) for week 1. 500 mg/day (2 capsules) for week 2. 750 mg/day (3 capsules) for week 3. 1000 mg/ day (4 capsules) for week 4.	Dietary supplement: Centella Asiatica; Centella Asiatica is a perennial, herbaceous plant that is sold as a dietary supplement in the United States under the name Gotu Kola. It has been used for centuries in Ayurvedic and Chinese medicine. Evidence suggests it may help with resilience to aging and cognitive decline. The product for this study will be produced by Arjuna Natural.; Other Names: gotu kola
Placebo Comparator: Placebo; Matched number of capsules per week. Capsules will contain microcrystalline cellulose.	Dietary supplement: Placebo Comparator; The comparator will contain microcystalline cellulose in matched capsules. The comparator product for this study will be produced by Arjuna Natural.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Function	Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.	Baseline
Endothelial Function	Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.	Day 1
Endothelial Function	Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability (HRV)	HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.	Baseline
Heart Rate Variability (HRV)	HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.	Day 1
Heart Rate Variability (HRV)	HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.	Week 4
Blood Pressure	Blood pressure will be measured at each visit with an automatic sphygmomanometer.	Baseline
Blood Pressure	Blood pressure will be measured at each visit with an automatic sphygmomanometer.	Day 1
Blood Pressure	Blood pressure will be measured at each visit with an automatic sphygmomanometer.	Week 4
Body Mass Index (BMI)	BMI will be calculated each visit by measuring the participant's height and weight.	Baseline
Body Mass Index (BMI)	BMI will be calculated each visit by measuring the participant's height and weight.	Day 1
Body Mass Index (BMI)	BMI will be calculated each visit by measuring the participant's height and weight.	Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose	Blood concentrations of glucose	Baseline
Blood glucose	Blood concentrations of glucose	Week 4
Urea Nitrogen	Blood concentrations of Urea Nitrogen	Baseline
Urea Nitrogen	Blood concentrations of Urea Nitrogen	Week 4
Creatinine	Blood concentrations of creatinine	Baseline
Creatinine	Blood concentrations of creatinine	Week 4
Urea Nitrogen to creatinine ratio	ratio of blood concentrations of urea nitrogen to creatinine	baseline
Urea Nitrogen to creatinine ratio	ratio of blood concentrations of urea nitrogen to creatinine	Week 4
Sodium	blood concentrations of Sodium	Baseline
Sodium	blood concentrations of Sodium	Week 4
Potassium	blood concentrations of Potassium	Baseline
Potassium	blood concentrations of Potassium	Week 4
Chloride	blood concentrations of Chloride	Baseline
Chloride	blood concentrations of Chloride	Week 4
Carbon Dioxide	blood concentration of carbon dioxide	baseline
Carbon Dioxide	blood concentration of carbon dioxide	week 4
Calcium	blood concentration of calcium	Baseline
Calcium	blood concentration of calcium	Week 4
Total Protein	Total protein in blood	Baseline
Total Protein	Total protein in blood	Week 4
Albumin	Concentration of albumin in blood	Baseline
Albumin	Concentration of albumin in blood	Week 4
Globulin	Concentration of globulin in blood	baseline
Globulin	Concentration of globulin in blood	Week 4
Albumin to Globulin ratio	Ratio of the blood concentrations of albumin to globulin	Baseline
Albumin to Globulin ratio	Ratio of the blood concentrations of albumin to globulin	Week 4
Bilirubin	Concentrations of bilirubin in blood	baseline
Bilirubin	Concentrations of bilirubin in blood	Week 4
Alkaline Phosphatase	Concentrations of alkaline phosphatase in blood	baseline
Alkaline Phosphatase	Concentrations of alkaline phosphatase in blood	Week 4
aspartate aminotransferase	Concentrations of aspartate aminotransferase in blood	Baseline
aspartate aminotransferase	Concentrations of aspartate aminotransferase in blood	Week 4
Alanine aminotransferase	Concentrations of Alanine aminotransferase in blood	baseline
Alanine aminotransferase	Concentrations of Alanine aminotransferase in blood	Week 4
Estimated glomerular filtration rate	glomerular filtration rate per 1.73 sqM estimated	baseline
Estimated glomerular filtration rate	glomerular filtration rate per 1.73 sqM estimated	Week 4
Adherence	Plasma concentrations of Asiatic Acid	Week 4
Adherence	Plasma concentrations of Medecassic Acid	Week 4

Collaborators and Investigators

• Sponsor: National University of Natural Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BZCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No