MedDataX Logo

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

NCT ID: NCT05645991

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2022-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aging Blood Pressure Arterial Stiffness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Coconut Sap Powder

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

Group Type EXPERIMENTAL

Coconut Sap Powder (CSP)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coconut Sap Powder (CSP)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

COCOZEN Coconut Inflorescence Sap

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ball State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brad Fleenor

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ball State University

Muncie, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COCOZEN

Identifier Type: -

Identifier Source: org_study_id