Aging, Arterial Stiffness, Blood Pressure
Conditions
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTCoconut Sap Powder (CSP)
CSP was given once daily (1.5 g/day) for 8 weeks.
DIETARY_SUPPLEMENTPlacebo
Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.
Sponsors
Ball State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index 18-35 kg/m2 * Brachial blood pressure \<140/90 * Nonsmoker * No known clinical disease, or suggestive signs or symptoms of clinical disease * Free of alcohol or drug dependence
Exclusion criteria
* taking any anti-hypertensive, lipid lowering or other cardiovascular altering medications * Known allergies to coconut or tree nuts (i.e., cashews, almonds, or pistachios) * Engaging in vigorous intensity exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in aortic stiffness | Baseline and 8 weeks | Carotid-femoral pulse wave velocity (meters/second) |
| Change in systolic and diastolic brachial blood pressure | Baseline and 8 weeks | Manual sphygmomanometer (mmHg) |
| Change in carotid systolic and diastolic blood pressure | Baseline and 8 weeks | Applanation tonometry of carotid artery (mmHg) |
| Change in carotid artery stiffness - beta stiffness index | Baseline and 8 weeks | Carotid artery Beta stiffness index (AU) |
| Change in carotid artery stiffness - carotid compliance | Baseline and 8 weeks | Carotid artery carotid compliance (mmHg/mm\^2) |
| Change in carotid artery stiffness - elastic modulus | Baseline and 8 weeks | Carotid artery elastic modulus (kilopascals, kPa) |
| Change in carotid artery stiffness - Young's modulus | Baseline and 8 weeks | Carotid artery Young's modulus (kilopascals, kPa) |
| Change in carotid artery stiffness - distensibility | Baseline and 8 weeks | Carotid artery distensibility (10\^-3/kilopascals) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in oxidative stress biomarkers - superoxide dismutase | Baseline and 8 weeks | Biomarker: Superoxide dismutase U/mL |
| Change in oxidative stress biomarkers - Oxidized low density lipoprotein | Baseline and 8 weeks | Biomarker: Oxidized Low density lipoprotein mU/L |
| Change in inflammatory biomarker - interleukin 6 | Baseline and 8 weeks | Biomarker: Interleukin 6 pg/mL |
| Change in inflammatory biomarker - interleukin 10 | Baseline and 8 weeks | Biomarker: Interleukin 10 pg/mL |
| Change in inflammatory biomarker - interleukin 1 beta | Baseline and 8 weeks | Biomarker: Interleukin 1 beta pg/mL |
| Change in inflammatory biomarker - tumor necrosis factor alpha | Baseline and 8 weeks | Biomarker: Tumor necrosis factor alpha pg/mL |
| Change in inflammatory biomarker - monocyte chemoattractant protein 1 | Baseline and 8 weeks | Biomarker: Monocyte chemoattractant protein 1 pg/mL |
| Change in inflammatory biomarker - high sensitivity C-reactive protein | Baseline and 8 weeks | Biomarker: High sensitivity C-reactive protein mg/mL |
| Change in oxidative stress biomarkers - Catalase | Baseline and 8 weeks | Biomarker: Catalase U/mL |
Countries
United States
Outcome results
None listed