Centella Asiatica in Older Adults

N/ANot Yet RecruitingNCT06472791

National University of Natural Medicine30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Endothelial Dysfunction

Interventions

Centella AsiaticaDIETARY_SUPPLEMENT

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.

Placebo ComparatorDIETARY_SUPPLEMENT

The comparator will contain microcystalline cellulose in matched capsules. The comparator product for this study will be produced by Arjuna Natural.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Helfgott Research Institute

Portland, Oregon, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Endothelial Function

Time frame: Day 1

Endothelial Function

Time frame: Week 4

Secondary Outcomes

Central Contacts

Benjamin Zimmerman, PhD

CONTACT

503-502-1862 bzimmerman@nunm.edu

Anders Gundersen, MS

CONTACT

503-552-1752 agundersen@nunm.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Heart Rate Variability (HRV)

HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.

Time frame: Baseline

Heart Rate Variability (HRV)

HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.

Time frame: Day 1

Heart Rate Variability (HRV)

HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.

Time frame: Week 4

Blood Pressure

Blood pressure will be measured at each visit with an automatic sphygmomanometer.

Time frame: Baseline

Blood Pressure

Blood pressure will be measured at each visit with an automatic sphygmomanometer.

Time frame: Day 1

Blood Pressure

Blood pressure will be measured at each visit with an automatic sphygmomanometer.

Time frame: Week 4

Body Mass Index (BMI)

BMI will be calculated each visit by measuring the participant's height and weight.

Time frame: Baseline

Body Mass Index (BMI)

BMI will be calculated each visit by measuring the participant's height and weight.

Time frame: Day 1

Body Mass Index (BMI)

BMI will be calculated each visit by measuring the participant's height and weight.

Time frame: Week 4