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

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

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).

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Aging; Arterial Stiffness
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Coconut Sap Powder (CSP)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Muncie, Indiana, United States, 47306
      • Ball State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.	Dietary supplement: Placebo; Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.
Experimental: Coconut Sap Powder; Capsules containing coconut sap powder (CSP; 1.5 g/day) were taken orally once daily for 8 weeks.	Dietary supplement: Coconut Sap Powder (CSP); CSP was given once daily (1.5 g/day) for 8 weeks.; Other Names: COCOZEN; 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

Collaborators and Investigators

• Sponsor: Ball State University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: COCOZEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No