Cardiovascular DiseaseG-CVDNCT02735486
Acute Effects of Ginger Extract Consumption on Risk Markers of Cardiovascular Disease
A study testing Ginger drink in people with Cardiovascular Disease, run by University of Reading at 1 site in United Kingdom.
Trial summary
The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease. 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 Disease
- What is being tested?
- Ginger drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Aug 2014
- 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
- Apparently healthy males,
- Age (30 - 65) years,
- Not diabetic or plasma glucose > 7 or on anti-diabetic drugs and not on anti- hypertensive drugs.
- Subjects < 10% risk of cardiovascular disease
Who cannot join
- Women,
- Men younger than 30 years and older that 65 years,
- Men who are sick or on anti-diabetic and anti-hypertensive drugs.
- Men who have history of heart attack or stroke within the last 12 months
- Men who are on lipids lowering drugs
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences
Reading, Berkshire, RG6 6AP
About this study
Official title: Randomized, Controlled Trial of Ginger Extract Consumption for Healthy Males at Risk of Developing Cardiovascular Disease
The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease.
Read the detailed description
A randomized, single-blind human intervention study involving 22 healthy male volunteers was designed to investigate the acute effects of ginger drink consumption on risk markers of cardiovascular disease (CVD). The primary outcome measure is reduction in blood pressure while the secondary outcome measures are improvement in flow mediated dilatation (FMD) and changes in plasma biochemical profile parameters related to CVD. Participants were given 300 ml of ginger extract or water (placebo) with breakfast, followed by a lunch at 2 hours on two visits separated by 2 weeks. Blood and urine samples were collected at regular intervals as well as blood pressure measurement done during the two visits. Vascular function was measured by flow mediated dilatation (FMD) and pulse wave velocity (PWV) at baseline, 2 and 4 hours after the the consumption of the study drink and placebo. The blood and urine samples were analysed for changes in lipid profile and other markers of CVD.
- Conditions
- Cardiovascular Disease
- Being tested
- Ginger drink, Placebo: Super pure water
- Keywords
- Ginger, blood pressure, flow mediated dilatation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger drinkDietary supplement
300 ml ginger drink
Placebo: Super pure waterDietary supplement
Placebo: Super pure water
| Study group | Role | What they receive |
|---|---|---|
| Ginger drink | Experimental | Experimental: Ginger drink (300 ml) to be consumed during the study visit Receives: Dietary Supplement: Ginger drink |
| Placebo: Super pure water | Placebo comparator | Super Pure water low in nitrate content Receives: Dietary Supplement: Placebo: Super pure water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in blood pressure (BP)
Reduction in blood pressure (BP)
Measured: Six (6) hours
Secondary outcomes (1)
Flow mediated dilatation
Improvement in vascular function measured as percentage (%) increase in FMD
Measured: Six (6) hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy PE Spencer, Professor, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735486
- Sponsor's protocol ID
- PHYTOVAS II
- Acronym
- G-CVD
- Status last verified
- Apr 2016
- First submitted
- 8 Dec 2015
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of Ginger Extract Consumption for Healthy Males at Risk of Developing Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02735486
- Acronym / sponsor ID
- G-CVD / PHYTOVAS II
- Conditions
- Cardiovascular Disease
- Keywords
- Ginger, blood pressure, flow mediated dilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Apr 2016 (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.
The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease.
Detailed description
A randomized, single-blind human intervention study involving 22 healthy male volunteers was designed to investigate the acute effects of ginger drink consumption on risk markers of cardiovascular disease (CVD). The primary outcome measure is reduction in blood pressure while the secondary outcome measures are improvement in flow mediated dilatation (FMD) and changes in plasma biochemical profile parameters related to CVD. Participants were given 300 ml of ginger extract or water (placebo) with breakfast, followed by a lunch at 2 hours on two visits separated by 2 weeks. Blood and urine samples were collected at regular intervals as well as blood pressure measurement done during the two visits. Vascular function was measured by flow mediated dilatation (FMD) and pulse wave velocity (PWV) at baseline, 2 and 4 hours after the the consumption of the study drink and placebo. The blood and urine samples were analysed for changes in lipid profile and other markers of CVD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger drink | Experimental | Dietary Supplement: Ginger drinkExperimental: Ginger drink (300 ml) to be consumed during the study visit |
| Placebo: Super pure water | Placebo comparator | Dietary Supplement: Placebo: Super pure waterSuper Pure water low in nitrate content |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Apparently healthy males,
- Age (30 - 65) years,
- Not diabetic or plasma glucose > 7 or on anti-diabetic drugs and not on anti- hypertensive drugs.
- Subjects < 10% risk of cardiovascular disease
Key exclusion criteria (5 listed)
- Women,
- Men younger than 30 years and older that 65 years,
- Men who are sick or on anti-diabetic and anti-hypertensive drugs.
- Men who have history of heart attack or stroke within the last 12 months
- Men who are on lipids lowering drugs
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 |
|---|---|---|
| Ginger drink300 ml ginger drink | Dietary supplement | Ginger drink |
| Placebo: Super pure waterPlacebo: Super pure water | Dietary supplement | Placebo: Super pure water |
Primary outcome
Reduction in blood pressure (BP)
Time frame: Six (6) hours
Reduction in blood pressure (BP)
1 secondary outcome
Flow mediated dilatation
Time frame: Six (6) hours
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 Apr 2016.
- 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.
Jeremy PE Spencer, Professor 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 Ginger drink in people with Cardiovascular Disease, 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 4 inclusion and 5 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 Apr 2016. 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?
Reduction in blood pressure (BP) (time frame: Six (6) hours). 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 Apr 2016.