Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Centlla Asiatica | Experimental | 250 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. |
|
| Placebo | Placebo Comparator | Matched number of capsules per week. Capsules will contain microcrystalline cellulose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Plasma concentrations of Asiatic Acid | Week 4 |
| Adherence | Plasma concentrations of Medecassic Acid | Week 4 |
Inclusion Criteria:
● Age 50 through 85, male or female
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helfgott Research Institute | Portland | Oregon | 97201 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C526146 | Centella asiatica extract |
Not provided
Not provided
Not provided
Participants will be randomized to take either a placebo or a Centella Asiatica-containing dietary supplement for four weeks
Not provided
Not provided
Not provided
|
|
| 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. |
|
| 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 |
| 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 |