NCT05645991

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

November 18, 2022

Last Update Submit

December 1, 2022

Conditions

AgingBlood PressureArterial Stiffness

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (9)

  • Change in inflammatory biomarker - interleukin 6

    Baseline and 8 weeks

  • Change in inflammatory biomarker - interleukin 10

    Baseline and 8 weeks

  • Change in inflammatory biomarker - interleukin 1 beta

    Baseline and 8 weeks

  • Change in inflammatory biomarker - tumor necrosis factor alpha

    Baseline and 8 weeks

  • Change in inflammatory biomarker - monocyte chemoattractant protein 1

    Baseline and 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Coconut Sap Powder

EXPERIMENTAL

Capsules containing coconut sap powder (CSP; 1.5 g/day) were taken orally once daily for 8 weeks.

Dietary Supplement: Coconut Sap Powder (CSP)

Interventions

Coconut Sap Powder (CSP)DIETARY_SUPPLEMENT

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

Also known as: COCOZEN, Coconut Inflorescence Sap
Coconut Sap Powder
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ball State University

Muncie, Indiana, 47306, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 12, 2022

Study Start

March 8, 2018

Primary Completion

February 28, 2020

Study Completion

January 20, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)