Clincosm LogoSign in Get a demo

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

Sponsor
Ball State University (Other)
Overall Status
Completed
CT.gov ID
NCT05645991
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
46.5
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Coconut Sap Powder (CSP)
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effects of Novel Coconut Inflorescence Sap (CSP; COCOZEN) on Age-related Cardiovascular Function
Actual Study Start Date :
Mar 8, 2018
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
Jan 20, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in aortic stiffness [Baseline and 8 weeks]

      Carotid-femoral pulse wave velocity (meters/second)

    2. Change in systolic and diastolic brachial blood pressure [Baseline and 8 weeks]

      Manual sphygmomanometer (mmHg)

    3. Change in carotid systolic and diastolic blood pressure [Baseline and 8 weeks]

      Applanation tonometry of carotid artery (mmHg)

    4. Change in carotid artery stiffness - beta stiffness index [Baseline and 8 weeks]

      Carotid artery Beta stiffness index (AU)

    5. Change in carotid artery stiffness - carotid compliance [Baseline and 8 weeks]

      Carotid artery carotid compliance (mmHg/mm^2)

    6. Change in carotid artery stiffness - elastic modulus [Baseline and 8 weeks]

      Carotid artery elastic modulus (kilopascals, kPa)

    7. Change in carotid artery stiffness - Young's modulus [Baseline and 8 weeks]

      Carotid artery Young's modulus (kilopascals, kPa)

    8. Change in carotid artery stiffness - distensibility [Baseline and 8 weeks]

      Carotid artery distensibility (10^-3/kilopascals)

    Secondary Outcome Measures

    1. Change in inflammatory biomarker - interleukin 6 [Baseline and 8 weeks]

      Biomarker: Interleukin 6 pg/mL

    2. Change in inflammatory biomarker - interleukin 10 [Baseline and 8 weeks]

      Biomarker: Interleukin 10 pg/mL

    3. Change in inflammatory biomarker - interleukin 1 beta [Baseline and 8 weeks]

      Biomarker: Interleukin 1 beta pg/mL

    4. Change in inflammatory biomarker - tumor necrosis factor alpha [Baseline and 8 weeks]

      Biomarker: Tumor necrosis factor alpha pg/mL

    5. Change in inflammatory biomarker - monocyte chemoattractant protein 1 [Baseline and 8 weeks]

      Biomarker: Monocyte chemoattractant protein 1 pg/mL

    6. Change in inflammatory biomarker - high sensitivity C-reactive protein [Baseline and 8 weeks]

      Biomarker: High sensitivity C-reactive protein mg/mL

    7. Change in oxidative stress biomarkers - superoxide dismutase [Baseline and 8 weeks]

      Biomarker: Superoxide dismutase U/mL

    8. Change in oxidative stress biomarkers - Catalase [Baseline and 8 weeks]

      Biomarker: Catalase U/mL

    9. Change in oxidative stress biomarkers - Oxidized low density lipoprotein [Baseline and 8 weeks]

      Biomarker: Oxidized Low density lipoprotein mU/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ball State University Muncie Indiana United States 47306

    Sponsors and Collaborators

    • Ball State University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brad Fleenor, Associate Professor, Ball State University
    ClinicalTrials.gov Identifier:
    NCT05645991
    Other Study ID Numbers:
    • COCOZEN
    First Posted:
    Dec 12, 2022
    Last Update Posted:
    Dec 12, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 12, 2022