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

Not Applicable

Completed

• Conditions: Blood Pressure; Aging; Arterial Stiffness

• Registration Number: NCT05645991
• Lead Sponsor: Ball State University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-08
• Primary Completion: 2020-02-28
• Study Completion: 2022-01-20
• Study First Submitted: 2022-11-18
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-01
• Last Update Submitted: 2022-12-01
• Study First Posted: 2022-12-12
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in systolic and diastolic brachial blood pressure	Baseline and 8 weeks	Manual sphygmomanometer (mmHg)
Change in carotid artery stiffness - beta stiffness index	Baseline and 8 weeks	Carotid artery Beta stiffness index (AU)
Change in carotid systolic and diastolic blood pressure	Baseline and 8 weeks	Applanation tonometry of carotid artery (mmHg)
Change in carotid artery stiffness - distensibility	Baseline and 8 weeks	Carotid artery distensibility (10\^-3/kilopascals)
Change in aortic stiffness	Baseline and 8 weeks	Carotid-femoral pulse wave velocity (meters/second)
Change in carotid artery stiffness - carotid compliance	Baseline and 8 weeks	Carotid artery carotid compliance (mmHg/mm\^2)
Change in carotid artery stiffness - elastic modulus	Baseline and 8 weeks	Carotid artery elastic modulus (kilopascals, kPa)
Change in carotid artery stiffness - Young's modulus	Baseline and 8 weeks	Carotid artery Young's modulus (kilopascals, kPa)

Secondary Outcome Measures

Name	Time	Method
Change in inflammatory biomarker - tumor necrosis factor alpha	Baseline and 8 weeks	Biomarker: Tumor necrosis factor alpha pg/mL
Change in inflammatory biomarker - high sensitivity C-reactive protein	Baseline and 8 weeks	Biomarker: High sensitivity C-reactive protein mg/mL
Change in oxidative stress biomarkers - Catalase	Baseline and 8 weeks	Biomarker: Catalase U/mL
Change in oxidative stress biomarkers - Oxidized low density lipoprotein	Baseline and 8 weeks	Biomarker: Oxidized Low density lipoprotein mU/L
Change in inflammatory biomarker - interleukin 6	Baseline and 8 weeks	Biomarker: Interleukin 6 pg/mL
Change in inflammatory biomarker - interleukin 10	Baseline and 8 weeks	Biomarker: Interleukin 10 pg/mL
Change in inflammatory biomarker - interleukin 1 beta	Baseline and 8 weeks	Biomarker: Interleukin 1 beta pg/mL
Change in inflammatory biomarker - monocyte chemoattractant protein 1	Baseline and 8 weeks	Biomarker: Monocyte chemoattractant protein 1 pg/mL
Change in oxidative stress biomarkers - superoxide dismutase	Baseline and 8 weeks	Biomarker: Superoxide dismutase U/mL

Trial Locations

Locations (1)

Ball State University; 🇺🇸 Muncie, Indiana, United States