Endothelial Dysfunction
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCentella 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.
DIETARY_SUPPLEMENTPlacebo Comparator
The comparator will contain microcystalline cellulose in matched capsules. The comparator product for this study will be produced by Arjuna Natural.
Sponsors
National University of Natural Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized to take either a placebo or a Centella Asiatica-containing dietary supplement for four weeks
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Function | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability (HRV) | Baseline | HRV will be measured continually at each visit via a wearable, wireless BodyGuard2. |
| Blood Pressure | Baseline | Blood pressure will be measured at each visit with an automatic sphygmomanometer. |
| Body Mass Index (BMI) | Baseline | BMI will be calculated each visit by measuring the participant's height and weight. |
Countries
United States
Outcome results
None listed