Clinical trial NCT05645991: Coconut Sugar Lowers Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
Official title: Effects of Novel Coconut Inflorescence Sap (CSP; COCOZEN) on Age-related Cardiovascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Blood Pressure
Arterial Stiffness
Lead sponsor: Ball State University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Change in aortic stiffness
timeFrame: Baseline and 8 weeks
measure: Change in systolic and diastolic brachial blood pressure
timeFrame: Baseline and 8 weeks
measure: Change in carotid systolic and diastolic blood pressure
timeFrame: Baseline and 8 weeks
measure: Change in carotid artery stiffness - beta stiffness index
timeFrame: Baseline and 8 weeks
measure: Change in carotid artery stiffness - carotid compliance
timeFrame: Baseline and 8 weeks
measure: Change in carotid artery stiffness - elastic modulus
timeFrame: Baseline and 8 weeks
measure: Change in carotid artery stiffness - Young's modulus
timeFrame: Baseline and 8 weeks
measure: Change in carotid artery stiffness - distensibility
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in inflammatory biomarker - interleukin 6
timeFrame: Baseline and 8 weeks
measure: Change in inflammatory biomarker - interleukin 10
timeFrame: Baseline and 8 weeks
measure: Change in inflammatory biomarker - interleukin 1 beta
timeFrame: Baseline and 8 weeks
measure: Change in inflammatory biomarker - tumor necrosis factor alpha
timeFrame: Baseline and 8 weeks
measure: Change in inflammatory biomarker - monocyte chemoattractant protein 1
timeFrame: Baseline and 8 weeks
measure: Change in inflammatory biomarker - high sensitivity C-reactive protein
timeFrame: Baseline and 8 weeks
measure: Change in oxidative stress biomarkers - superoxide dismutase
timeFrame: Baseline and 8 weeks
measure: Change in oxidative stress biomarkers - Catalase
timeFrame: Baseline and 8 weeks
measure: Change in oxidative stress biomarkers - Oxidized low density lipoprotein
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Muncie
country: United States
facility: Ball State University
state: Indiana
Study officials:
References: