AgingNCT05645991
Coconut Sugar Lowers Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
A study testing Coconut Sap Powder (CSP) in people with Aging and Blood Pressure, run by Ball State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Blood Pressure, Arterial Stiffness
- What is being tested?
- Coconut Sap Powder (CSP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 20 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Novel Coconut Inflorescence Sap (CSP; COCOZEN) on Age-related Cardiovascular Function
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).
- Conditions
- Aging, Blood Pressure, Arterial Stiffness
- Being tested
- Coconut Sap Powder (CSP), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut Sap Powder (CSP)Dietary supplement
Also called COCOZEN, Coconut Inflorescence Sap
CSP was given once daily (1.5 g/day) for 8 weeks.
PlaceboDietary supplement
Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks. Receives: 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. Receives: Dietary Supplement: Coconut Sap Powder (CSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aortic stiffness
Carotid-femoral pulse wave velocity (meters/second)
Measured: Baseline and 8 weeks
Change in systolic and diastolic brachial blood pressure
Manual sphygmomanometer (mmHg)
Measured: Baseline and 8 weeks
Change in carotid systolic and diastolic blood pressure
Applanation tonometry of carotid artery (mmHg)
Measured: Baseline and 8 weeks
Change in carotid artery stiffness - beta stiffness index
Carotid artery Beta stiffness index (AU)
Measured: Baseline and 8 weeks
Change in carotid artery stiffness - carotid compliance
Carotid artery carotid compliance (mmHg/mm^2)
Measured: Baseline and 8 weeks
Change in carotid artery stiffness - elastic modulus
Carotid artery elastic modulus (kilopascals, kPa)
Measured: Baseline and 8 weeks
Change in carotid artery stiffness - Young's modulus
Carotid artery Young's modulus (kilopascals, kPa)
Measured: Baseline and 8 weeks
Change in carotid artery stiffness - distensibility
Carotid artery distensibility (10^-3/kilopascals)
Measured: Baseline and 8 weeks
Secondary outcomes (9)
Change in inflammatory biomarker - interleukin 6
Biomarker: Interleukin 6 pg/mL
Measured: Baseline and 8 weeks
Change in inflammatory biomarker - interleukin 10
Biomarker: Interleukin 10 pg/mL
Measured: Baseline and 8 weeks
Change in inflammatory biomarker - interleukin 1 beta
Biomarker: Interleukin 1 beta pg/mL
Measured: Baseline and 8 weeks
Change in inflammatory biomarker - tumor necrosis factor alpha
Biomarker: Tumor necrosis factor alpha pg/mL
Measured: Baseline and 8 weeks
Change in inflammatory biomarker - monocyte chemoattractant protein 1
Biomarker: Monocyte chemoattractant protein 1 pg/mL
Measured: Baseline and 8 weeks
Change in inflammatory biomarker - high sensitivity C-reactive protein
Biomarker: High sensitivity C-reactive protein mg/mL
Measured: Baseline and 8 weeks
Change in oxidative stress biomarkers - superoxide dismutase
Biomarker: Superoxide dismutase U/mL
Measured: Baseline and 8 weeks
Change in oxidative stress biomarkers - Catalase
Biomarker: Catalase U/mL
Measured: Baseline and 8 weeks
Change in oxidative stress biomarkers - Oxidized low density lipoprotein
Biomarker: Oxidized Low density lipoprotein mU/L
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start8 Mar 2018
- Primary completion28 Feb 2020
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Fleenor, Ball State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645991
- Sponsor's protocol ID
- COCOZEN
- Status last verified
- Dec 2022
- First submitted
- 18 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Novel Coconut Inflorescence Sap (CSP; COCOZEN) on Age-related Cardiovascular Function
- ClinicalTrials.gov ID
- NCT05645991
- Acronym / sponsor ID
- COCOZEN
- Conditions
- Aging, Blood Pressure, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks. |
| Coconut Sap Powder | Experimental | Dietary Supplement: Coconut Sap Powder (CSP)Capsules containing coconut sap powder (CSP; 1.5 g/day) were taken orally once daily for 8 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coconut Sap Powder (CSP)Also: COCOZEN, Coconut Inflorescence SapCSP was given once daily (1.5 g/day) for 8 weeks. | Dietary supplement | Coconut Sap Powder |
| PlaceboCapsules containing aspartame (1.5 g/day) were taken orally once daily for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in aortic stiffness
Time frame: Baseline and 8 weeks
Carotid-femoral pulse wave velocity (meters/second)
Change in systolic and diastolic brachial blood pressure
Time frame: Baseline and 8 weeks
Manual sphygmomanometer (mmHg)
Change in carotid systolic and diastolic blood pressure
Time frame: Baseline and 8 weeks
Applanation tonometry of carotid artery (mmHg)
Change in carotid artery stiffness - beta stiffness index
Time frame: Baseline and 8 weeks
Carotid artery Beta stiffness index (AU)
Change in carotid artery stiffness - carotid compliance
Time frame: Baseline and 8 weeks
Carotid artery carotid compliance (mmHg/mm^2)
Change in carotid artery stiffness - elastic modulus
Time frame: Baseline and 8 weeks
Carotid artery elastic modulus (kilopascals, kPa)
Change in carotid artery stiffness - Young's modulus
Time frame: Baseline and 8 weeks
Carotid artery Young's modulus (kilopascals, kPa)
Change in carotid artery stiffness - distensibility
Time frame: Baseline and 8 weeks
Carotid artery distensibility (10^-3/kilopascals)
9 secondary outcomes
Change in inflammatory biomarker - interleukin 6
Time frame: Baseline and 8 weeks
Change in inflammatory biomarker - interleukin 10
Time frame: Baseline and 8 weeks
Change in inflammatory biomarker - interleukin 1 beta
Time frame: Baseline and 8 weeks
Change in inflammatory biomarker - tumor necrosis factor alpha
Time frame: Baseline and 8 weeks
Change in inflammatory biomarker - monocyte chemoattractant protein 1
Time frame: Baseline and 8 weeks
Change in inflammatory biomarker - high sensitivity C-reactive protein
Time frame: Baseline and 8 weeks
Change in oxidative stress biomarkers - superoxide dismutase
Time frame: Baseline and 8 weeks
Change in oxidative stress biomarkers - Catalase
Time frame: Baseline and 8 weeks
Change in oxidative stress biomarkers - Oxidized low density lipoprotein
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut Sap Powder (CSP) in people with Aging and Blood Pressure, run by Ball State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aortic stiffness (time frame: Baseline and 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.