Gout FlareNCT03621215
The Effect of Tart Cherry Juice on Risk of Gout Attacks
A study testing Tart cherry juice in people with Gout Flare and Gout Attack, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether consuming tart cherry juice daily for 12 months reduces the risk of gout attacks during this period. Individuals with an existing gout diagnosis and who have experienced at least one gout flare in the past year will be recruited to participate in this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gout Flare, Gout Attack
- What is being tested?
- Tart cherry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2019to 22 Apr 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- existing diagnosis of gout
- have experienced at least one gout flare in the previous 12 months
- able and willing to participate in the study and provide written informed consent
Who cannot join
- frequently consume cherries or cherry products e.g. cherry supplements and juice (more than once a week)
- severe renal impairment (estimated glomerular filtration rate of <30ml/min)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Food and Nutrition Group, Sheffield Hallam University
Sheffield, S1 1WB
About this study
Official title: The Effect of Tart Cherry Juice on Risk of Gout Attacks: a Randomised Controlled Trial
The purpose of this study is to determine whether consuming tart cherry juice daily for 12 months reduces the risk of gout attacks during this period. Individuals with an existing gout diagnosis and who have experienced at least one gout flare in the past year will be recruited to participate in this study.
Read the detailed description
Gout is a painful and often debilitating condition affecting around 3% of adults in the UK. It is a type of inflammatory arthritis caused by high levels of uric acid which is deposited as crystals in joints, resulting in painful gout flares. Cherries and cherry products have received attention for their possible role in gout management owing to their anti-inflammatory and anti-oxidant properties. Their consumption has been associated with a lower risk of gout attacks in one observational study. The consumption of cherries is also endorsed by several gout information websites and in the British Society of Rheumatology's 2017 guidelines for the management of gout. However, there is limited evidence underpinning these claims and existing studies tend to be short in duration and have small participant numbers. Gout attacks are sporadic in nature and so a long-term trial is required to clarify the therapeutic effect of cherries on gout attack risk.
The investigators are aiming to recruit 120 participants who have had at least one gout flare in the previous 12 months. Using the work of Rothenbacher et al., 2011, the chance of these individuals experiencing at least one attack in the next 12 months has been calculated at 11%. It is predicted that treatment with daily cherry juice consumption will reduce gout flare recurrence (primary outcome measure) to 1/4 of the rate of the actual recurrence i.e. to 2.7%. Using these figures, a sample size of 93 participants would provide power of 0.95 at a significance level of 0.05. A sample size of 120 participants allows for an approximate 20% attrition rate.
Participants will consume either 30 mL tart cherry juice (CherryActive) diluted to 250 mL with water or a fruit-flavoured placebo drink daily with breakfast for 12 months. Participants will be followed up at 6 and 12 months at the investigators' laboratory to study changes in gout flare frequency and intensity, uric acid levels and levels of inflammation. This will help determine if tart cherry juice could help reduce or even prevent gout attacks. Additionally, as gout is associated with increased cardiovascular disease (CVD) risk, changes in CVD risk markers, including blood pressure, arterial stiffness and cholesterol levels, will also be assessed.
Participants will be recruited through the use of posters, advertising on the UK Gout Society website, emails to large organisations and through letters sent from General Practitioners' (GP) surgeries to eligible patients. Potentially eligible patients will be identified by surgery staff using their patient database before contact information is passed to the research team at the surgery to prepare and send out invitation letters. As this method of recruitment involves accessing patient identifiable data (name and home address) prior to patient consent being given, an application to the Confidentiality Advisory Group (CAG) will be submitted for consideration.
A general linear mixed model analysis will be used to assess the effect of treatment allocation, time and their interaction on both primary and secondary outcome measures.
- Conditions
- Gout Flare, Gout Attack
- Being tested
- Tart cherry juice, Fruit-flavoured placebo drink
- Keywords
- tart cherries, gout, cardiovascular disease risk, gout attack, gout flare
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart cherry juiceDietary supplement
30 mL tart cherry juice concentrate (CherryActive, UK), diluted with water to 250 mL. This is consumed daily by participants, with breakfast, for 12 months.
Fruit-flavoured placebo drinkOther
Consumed daily by participants, with breakfast, for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Tart cherry juice | Experimental | 30 mL tart cherry concentrate (CherryActive, UK) diluted with 220 mL of water once per day (250 mL total volume per day). According to available manufacturers data, this is equivalent to consuming 90-100 fresh cherries per day. Receives: Dietary Supplement: Tart cherry juice |
| Fruit-flavoured placebo drink | Placebo comparator | Matched for sensory characteristics and energy (with the addition of glucose).
once per day (250 mL total volume per day) Receives: Other: Fruit-flavoured placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gout flare frequency
Difference in gout flare frequency in tart cherry juice group versus placebo group from baseline to 12 months. Recorded as number per month.
Measured: Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months
Secondary outcomes (11)
Change in gout flare intensity
Difference in gout flare intensity in tart cherry juice group versus placebo group from baseline to 12 months. Using a 0-10 Likert pain scale. The scale measures the pain of any gout flare. The possible score ranges from 0 for no pain through to 10 for worst pain imaginable. Change in pain scores between treatment and placebo groups will be compared throughout the duration of the intervention.
Measured: Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months
Changes in serum urate (in millimoles per litre (mmol/l))
Difference in serum urate in tart cherry juice group versus placebo group from baseline to 12 months.
Measured: Measured at 0, 6 and 12 months
Change in fractional excretion of uric acid (as a percentage, %)
Difference in fractional excretion of uric acid in tart cherry juice group versus placebo group from baseline to 12 months. Measured from 24 hour urine sample.
Measured: Measured at 0, 6 and 12 months
Change in inflammatory markers (in milligrams per litre (mg/l))
Difference in inflammatory markers (c reactive protein (CRP), inter leukin-6 (IL-6) and tumour necrosis factor- alpha (TNF-alpha)) in tart cherry juice group versus placebo group from baseline to 12 months. Measured using an enzyme-linked immunosorbent assay (ELISA).
Measured: Measured at 0, 6 and 12 months
Change in oxidative damage (in percentage (%) of tail DNA)
Difference in markers of oxidative stress in tart cherry juice group versus placebo group from baseline to 12 months. Measured using single-cell electrophoresis 'comet assay' as 8-oxo-dg levels in lymphocytes.
Measured: Measured at 0, 6 and 12 months
Change in antioxidant status (in percentage (%) of tail DNA)
Difference in antioxidant status in tart cherry juice group versus placebo group from baseline to 12 months. Measured using single-cell electrophoresis 'comet assay' as resistance of DNA lymphocyte to H202-induced DNA strand breaks.
Measured: Measured at 0, 6 and 12 months
Change in blood pressure (in millimetres of mercury (mmHg))
Difference in brachial and central blood pressure in tart cherry juice group versus placebo group from baseline to 12 months. Measured using a Vicorder.
Measured: Measured at 0, 6 and 12 months
Change in arterial stiffness (in meters per second (m/s))
Difference in arterial stiffness in tart cherry juice group versus placebo group from baseline to 12 months.
Measured: Measured at 0, 6 and 12 months
Change in lipid profile (in millimoles per litre (mmol/l))
Difference in total cholesterol, HDL cholesterol, LDL cholesterol and triacylglycerides) in tart cherry juice group versus placebo group from baseline to 12 months.
Measured: Measured at 0, 6 and 12 months
Height (in meters (m))
Height and weight will be combined to report BMI in kg/m^2. Difference in BMI in tart cherry juice group versus placebo group from baseline to 12 months.
Measured: Measured at 0, 6 and 12 months
Weight (in kilograms (kg))
Height and weight will be combined to report BMI in kg/m^2. Difference in BMI in tart cherry juice group versus placebo group from baseline to 12 months.
Measured: Measured at 0, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Jul 2019
- Primary completion22 Apr 2021
- Study completion22 Apr 2021
Why it stopped: Study was terminated due to COVID restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gout FlareStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to consume either tart cherry juice or a fruit-flavoured placebo drink (matched as closely as possible for energy and sensory characteristics) daily for 12 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Cherry Research Committee
- Responsible party
- Principal investigator, Tony Lynn, Sheffield Hallam University
- Investigators
- Margo Barker, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621215
- Sponsor's protocol ID
- ER7166682
- Other IDs
- AA4736173
- Status last verified
- Jun 2024
- First submitted
- 30 Jul 2018
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Neogi T, Chen C, Chaisson C, Hunter DJ, Choi HK. Cherry consumption and decreased risk of recurrent gout attacks. Arthritis Rheum. 2012 Dec;64(12):4004-11. doi: 10.1002/art.34677.
PubMed 23023818Jacob RA, Spinozzi GM, Simon VA, Kelley DS, Prior RL, Hess-Pierce B, Kader AA. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9. doi: 10.1093/jn/133.6.1826.
PubMed 12771324Kuo CF, Grainge MJ, Mallen C, Zhang W, Doherty M. Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study. Ann Rheum Dis. 2015 Apr;74(4):661-7. doi: 10.1136/annrheumdis-2013-204463. Epub 2014 Jan 15.
PubMed 24431399Cea Soriano L, Rothenbacher D, Choi HK, Garcia Rodriguez LA. Contemporary epidemiology of gout in the UK general population. Arthritis Res Ther. 2011 Mar 3;13(2):R39. doi: 10.1186/ar3272.
PubMed 21371293Rothenbacher D, Primatesta P, Ferreira A, Cea-Soriano L, Rodriguez LA. Frequency and risk factors of gout flares in a large population-based cohort of incident gout. Rheumatology (Oxford). 2011 May;50(5):973-81. doi: 10.1093/rheumatology/keq363. Epub 2011 Jan 12.
PubMed 21228059Dalbeth N, Ames R, Gamble GD, Horne A, Wong S, Kuhn-Sherlock B, MacGibbon A, McQueen FM, Reid IR, Palmano K. Effects of skim milk powder enriched with glycomacropeptide and G600 milk fat extract on frequency of gout flares: a proof-of-concept randomised controlled trial. Ann Rheum Dis. 2012 Jun;71(6):929-34. doi: 10.1136/annrheumdis-2011-200156. Epub 2012 Jan 23.
PubMed 22275296Lamb KL, Lynn A, Russell J, Barker ME. Effect of tart cherry juice on risk of gout attacks: protocol for a randomised controlled trial. BMJ Open. 2020 Mar 15;10(3):e035108. doi: 10.1136/bmjopen-2019-035108.
PubMed 32179562
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tart Cherry Juice on Risk of Gout Attacks: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03621215
- Acronym / sponsor ID
- ER7166682
- Conditions
- Gout Flare, Gout Attack
- Keywords
- tart cherries, gout, cardiovascular disease risk, gout attack, gout flare
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to COVID restrictions
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Cherry Research Committee
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 8 Aug 2018 (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 purpose of this study is to determine whether consuming tart cherry juice daily for 12 months reduces the risk of gout attacks during this period. Individuals with an existing gout diagnosis and who have experienced at least one gout flare in the past year will be recruited to participate in this study.
Detailed description
Gout is a painful and often debilitating condition affecting around 3% of adults in the UK. It is a type of inflammatory arthritis caused by high levels of uric acid which is deposited as crystals in joints, resulting in painful gout flares. Cherries and cherry products have received attention for their possible role in gout management owing to their anti-inflammatory and anti-oxidant properties. Their consumption has been associated with a lower risk of gout attacks in one observational study. The consumption of cherries is also endorsed by several gout information websites and in the British Society of Rheumatology's 2017 guidelines for the management of gout. However, there is limited evidence underpinning these claims and existing studies tend to be short in duration and have small participant numbers. Gout attacks are sporadic in nature and so a long-term trial is required to clarify the therapeutic effect of cherries on gout attack risk.
The investigators are aiming to recruit 120 participants who have had at least one gout flare in the previous 12 months. Using the work of Rothenbacher et al., 2011, the chance of these individuals experiencing at least one attack in the next 12 months has been calculated at 11%. It is predicted that treatment with daily cherry juice consumption will reduce gout flare recurrence (primary outcome measure) to 1/4 of the rate of the actual recurrence i.e. to 2.7%. Using these figures, a sample size of 93 participants would provide power of 0.95 at a significance level of 0.05. A sample size of 120 participants allows for an approximate 20% attrition rate.
Participants will consume either 30 mL tart cherry juice (CherryActive) diluted to 250 mL with water or a fruit-flavoured placebo drink daily with breakfast for 12 months. Participants will be followed up at 6 and 12 months at the investigators' laboratory to study changes in gout flare frequency and intensity, uric acid levels and levels of inflammation. This will help determine if tart cherry juice could help reduce or even prevent gout attacks. Additionally, as gout is associated with increased cardiovascular disease (CVD) risk, changes in CVD risk markers, including blood pressure, arterial stiffness and cholesterol levels, will also be assessed.
Participants will be recruited through the use of posters, advertising on the UK Gout Society website, emails to large organisations and through letters sent from General Practitioners' (GP) surgeries to eligible patients. Potentially eligible patients will be identified by surgery staff using their patient database before contact information is passed to the research team at the surgery to prepare and send out invitation letters. As this method of recruitment involves accessing patient identifiable data (name and home address) prior to patient consent being given, an application to the Confidentiality Advisory Group (CAG) will be submitted for consideration.
A general linear mixed model analysis will be used to assess the effect of treatment allocation, time and their interaction on both primary and secondary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to consume either tart cherry juice or a fruit-flavoured placebo drink (matched as closely as possible for energy and sensory characteristics) daily for 12 months.
| Arm | Type | Receives |
|---|---|---|
| Tart cherry juice | Experimental | Dietary Supplement: Tart cherry juice30 mL tart cherry concentrate (CherryActive, UK) diluted with 220 mL of water once per day (250 mL total volume per day). According to available manufacturers data, this is equivalent to consuming 90-100 fresh cherries per day. |
| Fruit-flavoured placebo drink | Placebo comparator | Other: Fruit-flavoured placebo drinkMatched for sensory characteristics and energy (with the addition of glucose). once per day (250 mL total volume per day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- existing diagnosis of gout
- have experienced at least one gout flare in the previous 12 months
- able and willing to participate in the study and provide written informed consent
Key exclusion criteria (2 listed)
- frequently consume cherries or cherry products e.g. cherry supplements and juice (more than once a week)
- severe renal impairment (estimated glomerular filtration rate of <30ml/min)
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 |
|---|---|---|
| Tart cherry juice30 mL tart cherry juice concentrate (CherryActive, UK), diluted with water to 250 mL. This is consumed daily by participants, with breakfast, for 12 months. | Dietary supplement | Tart cherry juice |
| Fruit-flavoured placebo drinkConsumed daily by participants, with breakfast, for 12 months. | Other | Fruit-flavoured placebo drink |
Primary outcome
Change in gout flare frequency
Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months
Difference in gout flare frequency in tart cherry juice group versus placebo group from baseline to 12 months. Recorded as number per month.
11 secondary outcomes
Change in gout flare intensity
Time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months
Changes in serum urate (in millimoles per litre (mmol/l))
Time frame: Measured at 0, 6 and 12 months
Change in fractional excretion of uric acid (as a percentage, %)
Time frame: Measured at 0, 6 and 12 months
Change in inflammatory markers (in milligrams per litre (mg/l))
Time frame: Measured at 0, 6 and 12 months
Change in oxidative damage (in percentage (%) of tail DNA)
Time frame: Measured at 0, 6 and 12 months
Change in antioxidant status (in percentage (%) of tail DNA)
Time frame: Measured at 0, 6 and 12 months
Change in blood pressure (in millimetres of mercury (mmHg))
Time frame: Measured at 0, 6 and 12 months
Change in arterial stiffness (in meters per second (m/s))
Time frame: Measured at 0, 6 and 12 months
Change in lipid profile (in millimoles per litre (mmol/l))
Time frame: Measured at 0, 6 and 12 months
Height (in meters (m))
Time frame: Measured at 0, 6 and 12 months
Weight (in kilograms (kg))
Time frame: Measured at 0, 6 and 12 months
Results and safety
The study was stopped early (reason given: Study was terminated due to COVID restrictions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 23023818Zhang Y, Neogi T, Chen C, Chaisson C, Hunter DJ, Choi HK. Cherry consumption and decreased risk of recurrent gout attacks. Arthritis Rheum. 2012 Dec;64(12):4004-11. doi: 10.1002/art.34677.
- Background: PubMed 12771324Jacob RA, Spinozzi GM, Simon VA, Kelley DS, Prior RL, Hess-Pierce B, Kader AA. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9. doi: 10.1093/jn/133.6.1826.
- Background: PubMed 24431399Kuo CF, Grainge MJ, Mallen C, Zhang W, Doherty M. Rising burden of gout in the UK but continuing suboptimal management: a nationwide population study. Ann Rheum Dis. 2015 Apr;74(4):661-7. doi: 10.1136/annrheumdis-2013-204463. Epub 2014 Jan 15.
- Background: PubMed 21371293Cea Soriano L, Rothenbacher D, Choi HK, Garcia Rodriguez LA. Contemporary epidemiology of gout in the UK general population. Arthritis Res Ther. 2011 Mar 3;13(2):R39. doi: 10.1186/ar3272.
- Background: PubMed 21228059Rothenbacher D, Primatesta P, Ferreira A, Cea-Soriano L, Rodriguez LA. Frequency and risk factors of gout flares in a large population-based cohort of incident gout. Rheumatology (Oxford). 2011 May;50(5):973-81. doi: 10.1093/rheumatology/keq363. Epub 2011 Jan 12.
- Background: PubMed 22275296Dalbeth N, Ames R, Gamble GD, Horne A, Wong S, Kuhn-Sherlock B, MacGibbon A, McQueen FM, Reid IR, Palmano K. Effects of skim milk powder enriched with glycomacropeptide and G600 milk fat extract on frequency of gout flares: a proof-of-concept randomised controlled trial. Ann Rheum Dis. 2012 Jun;71(6):929-34. doi: 10.1136/annrheumdis-2011-200156. Epub 2012 Jan 23.
- Derived from this study: PubMed 32179562Lamb KL, Lynn A, Russell J, Barker ME. Effect of tart cherry juice on risk of gout attacks: protocol for a randomised controlled trial. BMJ Open. 2020 Mar 15;10(3):e035108. doi: 10.1136/bmjopen-2019-035108.
- 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.
Margo Barker principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tart cherry juice in people with Gout Flare and Gout Attack, run by Sheffield Hallam University 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 Jun 2024. 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 was stopped early (reason given: Study was terminated due to COVID restrictions). Results are not available in the source record.
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 gout flare frequency (time frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621215, which also lists 7 linked publications.
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 27 Jun 2024.