Centella Asiatica in Older Adults
NCT Number: NCT06472791
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endothelial Dysfunction
Interventions: DIETARY_SUPPLEMENT: Centella Asiatica|DIETARY_SUPPLEMENT: Placebo Comparator
Sponsor: National University of Natural Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Helfgott Research Institute, Portland, Oregon, 97201, United States

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.

Primary Outcome Measures: 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: 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: Adherence, Plasma concentrations of Asiatic Acid, Week 4|Adherence, Plasma concentrations of Medecassic Acid, Week 4|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