Cardiovascular DiseasesPHYTOVASNCT02165553
Impact of Hibiscus on Cardiovascular Disease Risk
A study testing Hibiscus sabdariffa calyces extract as a cold drink in people with Cardiovascular Diseases, run by University of Reading at 1 site in United Kingdom.
Trial summary
Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a cold or hot drink and is available in the United Kingdom (UK) markets in different forms including tea bags. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Hibiscus sabdariffa calyces extract as a cold drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Mar 2015
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- 30 - 65 years
- 1 to 10 % Cardiovascular disease risk in 10 years
- Not taking blood pressure medication
- Not having liver or kidney disease
- Not anaemic
- A signed consent form
Who cannot join
- Female
- <30 or > 65 years
- <1 or >10 % Cardiovascular disease risk in 10 years
- Taking blood pressure medication
- Having liver or kidney disease
- Anaemic
Show all 10Show fewer
- Lack of signing consent form
- Vegan
- Individual with food allergy
- Sufferers of chronic illness
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading,
Reading, Berkshire, RG6 6AP
About this study
Official title: Acute Impact of Hibiscus Sabdariffa Calyces (HSC) Extract Consumption on Blood Pressure, Vascular Function and Other Cardiovascular Risk Factors
Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a cold or hot drink and is available in the United Kingdom (UK) markets in different forms including tea bags. There is preliminary data that support the hypothesis that HSC extract consumption has beneficial effect on blood vessel health and blood pressure reduction. Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the effect of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa calyces (HSC) compared with a matched control (water) on blood pressure and blood vessels function will be investigated after a high - fat mixed meal. This is with a view to determining the impacts of the extract on postprandial (after meal) blood pressure and other CVD risk factors. Results from the PHYTOVAS study could lead to identification of more dietary approaches that will contribute to CVD risk prevention and management.
- Conditions
- Cardiovascular Diseases
- Being tested
- Hibiscus sabdariffa calyces extract as a cold drink
- Keywords
- Hibiscus sabdariffa calyces, Blood Pressure, Vascular Function, Inflammation, Cardiometabolic risk markers, Systemic antioxidant capacity
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hibiscus sabdariffa calyces extract as a cold drinkDietary supplement
Also called Hibiscus flower tea, Hibiscus tea, Roselle
| Study group | Role | What they receive |
|---|---|---|
| Hibiscus sabdariffa calyces extract as a cold drink | Experimental | Subjects are asked to consume 250 ml of Hibiscus calyces drink after a high fat breakfast Receives: Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink |
| Water | Placebo comparator | Subjects are asked to consume 250 ml of water after a high fat breakfast Receives: Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline and hourly blood pressure
Measured: Baseline, hourly 4 times post baseline and then hourly for twelve hours at night
Secondary outcomes (6)
Change in Flow Mediated Vasodilation
Measured: Baseline, 2 and 4 hours post treatment
Change in blood lipids profile
Measured: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Change in Inflammatory marker: C - reactive protein (CRP)
Measured: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Change in plasma nitric oxide level
Measured: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Change in serum total antioxidant capacity
Measured: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Changes in serum or plasma glucose and insulin levels
Measured: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A. Lovegrove, BSc, PhD, RNutr, Principal investigator, University of ReadingJeremy P.E. Spencer, B.Sc, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165553
- Sponsor's protocol ID
- 13/40
- Acronym
- PHYTOVAS
- Status last verified
- Sep 2015
- First submitted
- 1 Jun 2014
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Impact of Hibiscus Sabdariffa Calyces (HSC) Extract Consumption on Blood Pressure, Vascular Function and Other Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT02165553
- Acronym / sponsor ID
- PHYTOVAS / 13/40
- Conditions
- Cardiovascular Diseases
- Keywords
- Hibiscus sabdariffa calyces, Blood Pressure, Vascular Function, Inflammation, Cardiometabolic risk markers, Systemic antioxidant capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Jun 2014 (estimated)
- 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.
Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a cold or hot drink and is available in the United Kingdom (UK) markets in different forms including tea bags. There is preliminary data that support the hypothesis that HSC extract consumption has beneficial effect on blood vessel health and blood pressure reduction. Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the effect of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa calyces (HSC) compared with a matched control (water) on blood pressure and blood vessels function will be investigated after a high - fat mixed meal. This is with a view to determining the impacts of the extract on postprandial (after meal) blood pressure and other CVD risk factors. Results from the PHYTOVAS study could lead to identification of more dietary approaches that will contribute to CVD risk prevention and management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hibiscus sabdariffa calyces extract as a cold drink | Experimental | Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drinkSubjects are asked to consume 250 ml of Hibiscus calyces drink after a high fat breakfast |
| Water | Placebo comparator | Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drinkSubjects are asked to consume 250 ml of water after a high fat breakfast |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male
- 30 - 65 years
- 1 to 10 % Cardiovascular disease risk in 10 years
- Not taking blood pressure medication
- Not having liver or kidney disease
Key exclusion criteria (10 listed)
- Female
- <30 or > 65 years
- <1 or >10 % Cardiovascular disease risk in 10 years
- Taking blood pressure medication
- Having liver or kidney disease
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 |
|---|---|---|
| Hibiscus sabdariffa calyces extract as a cold drinkAlso: Hibiscus flower tea, Hibiscus tea, Roselle | Dietary supplement | Hibiscus sabdariffa calyces extract as a cold drink, Water |
Primary outcome
Change in baseline and hourly blood pressure
Time frame: Baseline, hourly 4 times post baseline and then hourly for twelve hours at night
6 secondary outcomes
Change in Flow Mediated Vasodilation
Time frame: Baseline, 2 and 4 hours post treatment
Change in blood lipids profile
Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Change in Inflammatory marker: C - reactive protein (CRP)
Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Change in plasma nitric oxide level
Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Change in serum total antioxidant capacity
Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Changes in serum or plasma glucose and insulin levels
Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
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 7 Sep 2015.
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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.
Julie A. Lovegrove, BSc, PhD, RNutr principal investigator
University of Reading
Jeremy P.E. Spencer, B.Sc, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hibiscus sabdariffa calyces extract as a cold drink in people with Cardiovascular Diseases, run by University of Reading at 1 site in United Kingdom.
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 7 inclusion and 10 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 7 Sep 2015. 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 Kingdom. 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 baseline and hourly blood pressure (time frame: Baseline, hourly 4 times post baseline and then hourly for twelve hours at night). 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 7 Sep 2015.