Centella Asiatica in Older Adults

NCT06472791 — Not applicable, Completed, 23 participants, National University of Natural Medicine

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Effect of Centella Asiatica on Vascular Endothelial Function in Older Adults

RegistryNCT06472791
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, other
Enrollment23 (Actual)
SponsorNational University of Natural Medicine (Other)
ConditionsEndothelial Dysfunction
InterventionsCentella Asiatica, Placebo Comparator (Dietary supplement)
Datesstart 2025-02-01, primary completion 2025-12-31, completion 2025-12-31, first posted 2024-06-25, last updated 2026-07-01
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Endothelial Dysfunction All trials of Centella Asiatica All trials of Placebo Comparator

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Centlla AsiaticaExperimentalDietary Supplement: Centella Asiatica250 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.
PlaceboPlacebo comparatorDietary Supplement: Placebo ComparatorMatched number of capsules per week. Capsules will contain microcrystalline cellulose.
  • Centella Asiatica (Dietary supplement), also known as gotu kola: 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 Comparator (Dietary supplement): The comparator will contain microcystalline cellulose in matched capsules. The comparator product for this study will be produced by Arjuna Natural.

+Outcome measures

Primary outcomes

  • 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.
  • Endothelial Function [Day 1]: 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.
  • Endothelial Function [Week 4]: 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 outcomes

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

Other outcomes

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

+Eligibility

Sex: All, ages: 50 Years to 85 Years, accepts healthy volunteers

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)

FacilityCityCountryStatus
Helfgott Research InstitutePortland, OregonUnited States