Blood PressurePhase 1/2NCT01935362
Impact of Oranges on Cardiovascular Health
A Phase 1/2 study testing Citrus supplement in people with Blood Pressure and Endothelial Dysfunction, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Cardiovascular disease (CVD) is the leading cause of deaths in the Western world. Established risk factors include high LDL cholesterol, high blood pressure and diabetes. Poor blood vessel health is considered a predictor of future CVD risk, but can be reversed. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Endothelial Dysfunction, Cardiovascular Disease Risk Reduction
- What is being tested?
- Citrus supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Mar 2014
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No known cardiovascular disease or diabetes
- Age between 30-60 years
- Heavier than average (Body mass index, BMI ≥ 25 kg/m2)
- Currently non smoker
- Willing to consume orange juice supplements for 2 months
- Male and female are equally eligible as not mentioned on advert
Who cannot join
- Those who Taken any antibiotics in the 2 months prior to the study
- Those who consume dietary or herbal supplements
- previous surgery on gastrointestinal tract
- Those who currently taking medication
- Current smokers, or ex-smokers ceasing < 3 months ago
- pregnant or breast feeding
- Those with known allergies to the intervention treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School Of Food Science and Nutrition, University Of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: Bioavailability of Flavanones Compounds and Their Impact on Cardiovascular Health
Cardiovascular disease (CVD) is the leading cause of deaths in the Western world. Established risk factors include high LDL cholesterol, high blood pressure and diabetes. Poor blood vessel health is considered a predictor of future CVD risk, but can be reversed. Several different measurements can be used to determine blood vessel health; such as blood pressure (BP), and newer techniques which measure blood flow through the arteries after a blood pressure cuff restricts blood flow for a few minutes in one arm.
Flavonoids are compounds found in plant-based foods, and are associated with a reduced risk of CVD. From the previous studies, there is strong evidence that orange juice and citrus foods which have higher amount of specific citrus flavonoids improved cardiovascular risk factors such as BP and blood vessel health. Absorption of citrus flavonoids occurs in the colon after bacteria breakdown the forms found in food. After the flavonoids are absorbed into the blood they are modification by liver enzymes before they are excreted in the urine. A large range of citrus flavonoid have been found excreted in the urinary, ranging anywhere from 0-57% of the dose. Variation in the potential health effect may reflect the level of the citrus flavonoid absorbed, and this is not often considered in human studies.
Read more
This study is a 4-week double-blinded, randomized, cross-over intervention trial using a commercially-available orange juice supplement and a placebo control. The aims of the study are to determine whether orange juice supplements reduce blood pressure and improve blood vessel health after 4 weeks. Furthermore, to determine if there is a relationship between absorption of flavonoids (as measured by urinary excretion) and changes in blood pressure or blood vessel health.
The participants will need to attend 4 sessions on 4 separate study days, every 4 weeks for 12 weeks. On each study day they will have their weight, height, waist circumference, and blood pressure measured. A finger-prick blood sample, using a single-use lancet (Accu-Chek Safe T Pro Plus), will be taken to check the fasting blood glucose level. Blood flow in fingertips will be monitored before and after reducing blood flow in your forearm using a blood pressure cuff (called an EndoPAT). Participants will be asked to collect urine for 24 hr on each of the study days, and to consume the supplements provided daily for two sets of 4 weeks (there will be 4 weeks in the middle without any supplements).
An improvement in blood pressure and/or blood flow will provide evidence that blood vessel health has improved through short-term (4 week) use of a citrus flavonoid supplement
- Being tested
- Citrus supplement, Placebo
- Keywords
- Flavanones, Bioavailability, Blood vessel health, Blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus supplementDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo administered to participant Receives: Dietary Supplement: Placebo |
| Citrus supplement | Active comparator | Citrus supplement administered to participant Receives: Dietary Supplement: Citrus supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Change in systolic and diastolic blood pressure
Measured: Baseline and 4 weeks
An improvement in blood flow
Change in blood flow using Endo-PAT device
Measured: Baseline and 4 weeks
Secondary outcomes (2)
blood glucose
Change in blood glucose level in plasma,
Measured: Baseline and 4 weeks
bioavailability of flavanones compounds
Change of urine flavanones from the baseline and after 4 weeks of each arm
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Andrea Day and Prof Gary Williamson
- Responsible party
- Principal investigator, Abdurrahman M Sweidan, University of Leeds
- Investigators
- Abdurrahman M Sweidan, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935362
- Sponsor's protocol ID
- MEEC 12-025
- Status last verified
- Mar 2014
- First submitted
- 20 Aug 2013
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Flavanones Compounds and Their Impact on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT01935362
- Acronym / sponsor ID
- MEEC 12-025
- Keywords
- Flavanones, Bioavailability, Blood vessel health, Blood glucose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Dr Andrea Day and Prof Gary Williamson
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Sep 2013 (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.
Cardiovascular disease (CVD) is the leading cause of deaths in the Western world. Established risk factors include high LDL cholesterol, high blood pressure and diabetes. Poor blood vessel health is considered a predictor of future CVD risk, but can be reversed. Several different measurements can be used to determine blood vessel health; such as blood pressure (BP), and newer techniques which measure blood flow through the arteries after a blood pressure cuff restricts blood flow for a few minutes in one arm.
Flavonoids are compounds found in plant-based foods, and are associated with a reduced risk of CVD. From the previous studies, there is strong evidence that orange juice and citrus foods which have higher amount of specific citrus flavonoids improved cardiovascular risk factors such as BP and blood vessel health. Absorption of citrus flavonoids occurs in the colon after bacteria breakdown the forms found in food. After the flavonoids are absorbed into the blood they are modification by liver enzymes before they are excreted in the urine. A large range of citrus flavonoid have been found excreted in the urinary, ranging anywhere from 0-57% of the dose. Variation in the potential health effect may reflect the level of the citrus flavonoid absorbed, and this is not often considered in human studies.
This study is a 4-week double-blinded, randomized, cross-over intervention trial using a commercially-available orange juice supplement and a placebo control. The aims of the study are to determine whether orange juice supplements reduce blood pressure and improve blood vessel health after 4 weeks. Furthermore, to determine if there is a relationship between absorption of flavonoids (as measured by urinary excretion) and changes in blood pressure or blood vessel health.
The participants will need to attend 4 sessions on 4 separate study days, every 4 weeks for 12 weeks. On each study day they will have their weight, height, waist circumference, and blood pressure measured. A finger-prick blood sample, using a single-use lancet (Accu-Chek Safe T Pro Plus), will be taken to check the fasting blood glucose level. Blood flow in fingertips will be monitored before and after reducing blood flow in your forearm using a blood pressure cuff (called an EndoPAT). Participants will be asked to collect urine for 24 hr on each of the study days, and to consume the supplements provided daily for two sets of 4 weeks (there will be 4 weeks in the middle without any supplements).
An improvement in blood pressure and/or blood flow will provide evidence that blood vessel health has improved through short-term (4 week) use of a citrus flavonoid supplement
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo administered to participant |
| Citrus supplement | Active comparator | Dietary Supplement: Citrus supplementCitrus supplement administered to participant |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- No known cardiovascular disease or diabetes
- Age between 30-60 years
- Heavier than average (Body mass index, BMI ≥ 25 kg/m2)
- Currently non smoker
- Willing to consume orange juice supplements for 2 months
Key exclusion criteria (7 listed)
- Those who Taken any antibiotics in the 2 months prior to the study
- Those who consume dietary or herbal supplements
- previous surgery on gastrointestinal tract
- Those who currently taking medication
- Current smokers, or ex-smokers ceasing < 3 months ago
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 |
|---|---|---|
| Citrus supplement | Dietary supplement | Citrus supplement |
| Placebo | Dietary supplement | placebo |
Primary outcome
blood pressure
Time frame: Baseline and 4 weeks
Change in systolic and diastolic blood pressure
An improvement in blood flow
Time frame: Baseline and 4 weeks
Change in blood flow using Endo-PAT device
2 secondary outcomes
blood glucose
Time frame: Baseline and 4 weeks
bioavailability of flavanones compounds
Time frame: Baseline and 4 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 1 Apr 2014.
- Click here for more information about this study: Impact of oranges on cardiovascular healthLink provided by the sponsor.
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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.
Abdurrahman M Sweidan principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Citrus supplement in people with Blood Pressure and Endothelial Dysfunction, run by University of Leeds 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 6 inclusion and 7 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 1 Apr 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
blood pressure (time frame: Baseline and 4 weeks). The study lists 2 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 1 Apr 2014.