Coconut Sugar Lowers Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults

Study Overview
=================
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).

Official Title
-----------------
Effects of Novel Coconut Inflorescence Sap (CSP; COCOZEN) on Age-related Cardiovascular Function

Conditions
-----------------
Arterial Stiffness, Aging, Blood Pressure

Intervention / Treatment
-----------------
* Dietary Supplement: Coconut Sap Powder (CSP)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks. | Dietary Supplement: Placebo<br>* Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.<br>|
| Experimental: Coconut Sap Powder<br>Capsules containing coconut sap powder (CSP; 1.5 g/day) were taken orally once daily for 8 weeks. | Dietary Supplement: Coconut Sap Powder (CSP)<br>* CSP was given once daily (1.5 g/day) for 8 weeks.<br>* Other names: Coconut Inflorescence Sap;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |