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Completed

NCT Number: NCT06472791

Centella Asiatica 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.

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Key information

Conditions

Endothelial Dysfunction

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helfgott Research Institute

Portland, Oregon, 97201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Centella Asiatica

Dietary 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.

Other names: gotu kola

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.

Primary outcomes

  1. Endothelial Function

    Time frame: 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.

  2. Endothelial Function

    Time frame: 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.

  3. Endothelial Function

    Time frame: 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

  1. Heart Rate Variability (HRV)

    Time frame: Baseline

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

  2. Heart Rate Variability (HRV)

    Time frame: Day 1

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

  3. Heart Rate Variability (HRV)

    Time frame: Week 4

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

  4. Blood Pressure

    Time frame: Baseline

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

  5. Blood Pressure

    Time frame: Day 1

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

  6. Blood Pressure

    Time frame: Week 4

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

  7. Body Mass Index (BMI)

    Time frame: Baseline

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

  8. Body Mass Index (BMI)

    Time frame: Day 1

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

  9. Body Mass Index (BMI)

    Time frame: Week 4

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

Other outcomes

  1. Adherence

    Time frame: Week 4

    Plasma concentrations of Asiatic Acid

  2. Adherence

    Time frame: Week 4

    Plasma concentrations of Medecassic Acid

  3. Blood glucose

    Time frame: Baseline

    Blood concentrations of glucose

  4. Blood glucose

    Time frame: Week 4

    Blood concentrations of glucose

  5. Urea Nitrogen

    Time frame: Baseline

    Blood concentrations of Urea Nitrogen

  6. Urea Nitrogen

    Time frame: Week 4

    Blood concentrations of Urea Nitrogen

  7. Creatinine

    Time frame: Baseline

    Blood concentrations of creatinine

  8. Creatinine

    Time frame: Week 4

    Blood concentrations of creatinine

  9. Urea Nitrogen to creatinine ratio

    Time frame: baseline

    ratio of blood concentrations of urea nitrogen to creatinine

  10. Urea Nitrogen to creatinine ratio

    Time frame: Week 4

    ratio of blood concentrations of urea nitrogen to creatinine

  11. Sodium

    Time frame: Baseline

    blood concentrations of Sodium

  12. Sodium

    Time frame: Week 4

    blood concentrations of Sodium

  13. Potassium

    Time frame: Baseline

    blood concentrations of Potassium

  14. Potassium

    Time frame: Week 4

    blood concentrations of Potassium

  15. Chloride

    Time frame: Baseline

    blood concentrations of Chloride

  16. Chloride

    Time frame: Week 4

    blood concentrations of Chloride

  17. Carbon Dioxide

    Time frame: baseline

    blood concentration of carbon dioxide

  18. Carbon Dioxide

    Time frame: week 4

    blood concentration of carbon dioxide

  19. Calcium

    Time frame: Baseline

    blood concentration of calcium

  20. Calcium

    Time frame: Week 4

    blood concentration of calcium

  21. Total Protein

    Time frame: Baseline

    Total protein in blood

  22. Total Protein

    Time frame: Week 4

    Total protein in blood

  23. Albumin

    Time frame: Baseline

    Concentration of albumin in blood

  24. Albumin

    Time frame: Week 4

    Concentration of albumin in blood

  25. Globulin

    Time frame: baseline

    Concentration of globulin in blood

  26. Globulin

    Time frame: Week 4

    Concentration of globulin in blood

  27. Albumin to Globulin ratio

    Time frame: Baseline

    Ratio of the blood concentrations of albumin to globulin

  28. Albumin to Globulin ratio

    Time frame: Week 4

    Ratio of the blood concentrations of albumin to globulin

  29. Bilirubin

    Time frame: baseline

    Concentrations of bilirubin in blood

  30. Bilirubin

    Time frame: Week 4

    Concentrations of bilirubin in blood

  31. Alkaline Phosphatase

    Time frame: baseline

    Concentrations of alkaline phosphatase in blood

  32. Alkaline Phosphatase

    Time frame: Week 4

    Concentrations of alkaline phosphatase in blood

  33. aspartate aminotransferase

    Time frame: Baseline

    Concentrations of aspartate aminotransferase in blood

  34. aspartate aminotransferase

    Time frame: Week 4

    Concentrations of aspartate aminotransferase in blood

  35. Alanine aminotransferase

    Time frame: baseline

    Concentrations of Alanine aminotransferase in blood

  36. Alanine aminotransferase

    Time frame: Week 4

    Concentrations of Alanine aminotransferase in blood

  37. Estimated glomerular filtration rate

    Time frame: baseline

    glomerular filtration rate per 1.73 sqM estimated

  38. Estimated glomerular filtration rate

    Time frame: Week 4

    glomerular filtration rate per 1.73 sqM estimated

Sponsors and collaborators

Lead sponsor

National University of Natural Medicine

Other

Registry information

Official study title

Effect of Centella Asiatica on Vascular Endothelial Function in Older Adults

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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