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Completed

NCT Number: NCT05645991

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

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).

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Key information

Conditions

Aging Arterial Stiffness Blood Pressure

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ball State University

Muncie, Indiana, 47306, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coconut Sap Powder (CSP)

Dietary Supplement

CSP was given once daily (1.5 g/day) for 8 weeks.

Other names: COCOZEN, Coconut Inflorescence Sap

Placebo

Dietary Supplement

Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.

Primary outcomes

  1. Change in aortic stiffness

    Time frame: Baseline and 8 weeks

    Carotid-femoral pulse wave velocity (meters/second)

  2. Change in systolic and diastolic brachial blood pressure

    Time frame: Baseline and 8 weeks

    Manual sphygmomanometer (mmHg)

  3. Change in carotid systolic and diastolic blood pressure

    Time frame: Baseline and 8 weeks

    Applanation tonometry of carotid artery (mmHg)

  4. Change in carotid artery stiffness - beta stiffness index

    Time frame: Baseline and 8 weeks

    Carotid artery Beta stiffness index (AU)

  5. Change in carotid artery stiffness - carotid compliance

    Time frame: Baseline and 8 weeks

    Carotid artery carotid compliance (mmHg/mm^2)

  6. Change in carotid artery stiffness - elastic modulus

    Time frame: Baseline and 8 weeks

    Carotid artery elastic modulus (kilopascals, kPa)

  7. Change in carotid artery stiffness - Young's modulus

    Time frame: Baseline and 8 weeks

    Carotid artery Young's modulus (kilopascals, kPa)

  8. Change in carotid artery stiffness - distensibility

    Time frame: Baseline and 8 weeks

    Carotid artery distensibility (10^-3/kilopascals)

Secondary outcomes

  1. Change in inflammatory biomarker - interleukin 6

    Time frame: Baseline and 8 weeks

    Biomarker: Interleukin 6 pg/mL

  2. Change in inflammatory biomarker - interleukin 10

    Time frame: Baseline and 8 weeks

    Biomarker: Interleukin 10 pg/mL

  3. Change in inflammatory biomarker - interleukin 1 beta

    Time frame: Baseline and 8 weeks

    Biomarker: Interleukin 1 beta pg/mL

  4. Change in inflammatory biomarker - tumor necrosis factor alpha

    Time frame: Baseline and 8 weeks

    Biomarker: Tumor necrosis factor alpha pg/mL

  5. Change in inflammatory biomarker - monocyte chemoattractant protein 1

    Time frame: Baseline and 8 weeks

    Biomarker: Monocyte chemoattractant protein 1 pg/mL

  6. Change in inflammatory biomarker - high sensitivity C-reactive protein

    Time frame: Baseline and 8 weeks

    Biomarker: High sensitivity C-reactive protein mg/mL

  7. Change in oxidative stress biomarkers - superoxide dismutase

    Time frame: Baseline and 8 weeks

    Biomarker: Superoxide dismutase U/mL

  8. Change in oxidative stress biomarkers - Catalase

    Time frame: Baseline and 8 weeks

    Biomarker: Catalase U/mL

  9. Change in oxidative stress biomarkers - Oxidized low density lipoprotein

    Time frame: Baseline and 8 weeks

    Biomarker: Oxidized Low density lipoprotein mU/L

Sponsors and collaborators

Lead sponsor

Ball State University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Dec 12, 2022
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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