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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05645991
• Other study ID #: COCOZEN
• Status: Completed
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: January 20, 2022

Study information

• Verified date: December 2022
• Source: Ball State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 20, 2022
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Arterial Stiffness
• Blood Pressure

Intervention

Dietary Supplement:
• Coconut Sap Powder (CSP)
CSP was given once daily (1.5 g/day) for 8 weeks.
• Placebo
Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.

Locations

Country	Name	City	State
United States	Ball State University	Muncie	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Ball State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in aortic stiffness	Carotid-femoral pulse wave velocity (meters/second)	Baseline and 8 weeks
Primary	Change in systolic and diastolic brachial blood pressure	Manual sphygmomanometer (mmHg)	Baseline and 8 weeks
Primary	Change in carotid systolic and diastolic blood pressure	Applanation tonometry of carotid artery (mmHg)	Baseline and 8 weeks
Primary	Change in carotid artery stiffness - beta stiffness index	Carotid artery Beta stiffness index (AU)	Baseline and 8 weeks
Primary	Change in carotid artery stiffness - carotid compliance	Carotid artery carotid compliance (mmHg/mm^2)	Baseline and 8 weeks
Primary	Change in carotid artery stiffness - elastic modulus	Carotid artery elastic modulus (kilopascals, kPa)	Baseline and 8 weeks
Primary	Change in carotid artery stiffness - Young's modulus	Carotid artery Young's modulus (kilopascals, kPa)	Baseline and 8 weeks
Primary	Change in carotid artery stiffness - distensibility	Carotid artery distensibility (10^-3/kilopascals)	Baseline and 8 weeks
Secondary	Change in inflammatory biomarker - interleukin 6	Biomarker: Interleukin 6 pg/mL	Baseline and 8 weeks
Secondary	Change in inflammatory biomarker - interleukin 10	Biomarker: Interleukin 10 pg/mL	Baseline and 8 weeks
Secondary	Change in inflammatory biomarker - interleukin 1 beta	Biomarker: Interleukin 1 beta pg/mL	Baseline and 8 weeks
Secondary	Change in inflammatory biomarker - tumor necrosis factor alpha	Biomarker: Tumor necrosis factor alpha pg/mL	Baseline and 8 weeks
Secondary	Change in inflammatory biomarker - monocyte chemoattractant protein 1	Biomarker: Monocyte chemoattractant protein 1 pg/mL	Baseline and 8 weeks
Secondary	Change in inflammatory biomarker - high sensitivity C-reactive protein	Biomarker: High sensitivity C-reactive protein mg/mL	Baseline and 8 weeks
Secondary	Change in oxidative stress biomarkers - superoxide dismutase	Biomarker: Superoxide dismutase U/mL	Baseline and 8 weeks
Secondary	Change in oxidative stress biomarkers - Catalase	Biomarker: Catalase U/mL	Baseline and 8 weeks
Secondary	Change in oxidative stress biomarkers - Oxidized low density lipoprotein	Biomarker: Oxidized Low density lipoprotein mU/L	Baseline and 8 weeks