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The goal of this intervention is to determine the efficacy of coconut sap powder (CSP) to lower arterial stiffness and blood pressure in middle-aged and older adults. Participants will be randomized to the CSP arm or Placebo arm of the study. Primary endpoints include: aortic stiffness assessed by carotid-femoral pulse wave velocity, resting brachial and (non-invasive) carotid blood pressure, and carotid stiffness (e.g. Beta stiffness index, Carotid compliance, Elastic modulus, Distensibility).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks. |
|
| Coconut Sap Powder | Experimental | Capsules containing coconut sap powder (CSP; 1.5 g/day) were taken orally once daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coconut Sap Powder (CSP) | Dietary Supplement | CSP was given once daily (1.5 g/day) for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in aortic stiffness | Carotid-femoral pulse wave velocity (meters/second) | Baseline and 8 weeks |
| Change in systolic and diastolic brachial blood pressure | Manual sphygmomanometer (mmHg) | Baseline and 8 weeks |
| Change in carotid systolic and diastolic blood pressure | Applanation tonometry of carotid artery (mmHg) | Baseline and 8 weeks |
| Change in carotid artery stiffness - beta stiffness index | Carotid artery Beta stiffness index (AU) | Baseline and 8 weeks |
| Change in carotid artery stiffness - carotid compliance | Carotid artery carotid compliance (mmHg/mm^2) | Baseline and 8 weeks |
| Change in carotid artery stiffness - elastic modulus | Carotid artery elastic modulus (kilopascals, kPa) | Baseline and 8 weeks |
| Change in carotid artery stiffness - Young's modulus | Carotid artery Young's modulus (kilopascals, kPa) | Baseline and 8 weeks |
| Change in carotid artery stiffness - distensibility | Carotid artery distensibility (10^-3/kilopascals) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory biomarker - interleukin 6 | Biomarker: Interleukin 6 pg/mL | Baseline and 8 weeks |
| Change in inflammatory biomarker - interleukin 10 | Biomarker: Interleukin 10 pg/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ball State University | Muncie | Indiana | 47306 | United States |
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| Placebo | Dietary Supplement | Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks. |
|
| Baseline and 8 weeks |
| Baseline and 8 weeks |
| Change in inflammatory biomarker - interleukin 1 beta | Biomarker: Interleukin 1 beta pg/mL | Baseline and 8 weeks |
| Change in inflammatory biomarker - tumor necrosis factor alpha | Biomarker: Tumor necrosis factor alpha pg/mL | Baseline and 8 weeks |
| Change in inflammatory biomarker - monocyte chemoattractant protein 1 | Biomarker: Monocyte chemoattractant protein 1 pg/mL | Baseline and 8 weeks |
| Change in inflammatory biomarker - high sensitivity C-reactive protein | Biomarker: High sensitivity C-reactive protein mg/mL | Baseline and 8 weeks |
| Change in oxidative stress biomarkers - superoxide dismutase | Biomarker: Superoxide dismutase U/mL | Baseline and 8 weeks |
| Change in oxidative stress biomarkers - Catalase | Biomarker: Catalase U/mL | Baseline and 8 weeks |
| Change in oxidative stress biomarkers - Oxidized low density lipoprotein | Biomarker: Oxidized Low density lipoprotein mU/L | Baseline and 8 weeks |