Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 990 for:    gout

The Effect of Tart Cherry Juice on Risk of Gout Attacks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03621215
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Cherry Research Committee
Information provided by (Responsible Party):
Tony Lynn, Sheffield Hallam University

Brief 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.

Condition or disease Intervention/treatment Phase
Gout Flare Gout Attack Dietary Supplement: Tart cherry juice Other: Fruit-flavoured placebo drink Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Tart Cherry Juice on Risk of Gout Attacks: a Randomised Controlled Trial
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Tart cherry juice
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.
Dietary Supplement: Tart cherry juice
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.

Placebo Comparator: Fruit-flavoured placebo drink

Matched for sensory characteristics and energy (with the addition of glucose).

once per day (250 mL total volume per day)

Other: Fruit-flavoured placebo drink
Consumed daily by participants, with breakfast, for 12 months.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in gout flare intensity [ Time Frame: Measured at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months ]
    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.

  2. Changes in serum urate (in millimoles per litre (mmol/l)) [ Time Frame: Measured at 0, 6 and 12 months ]
    Difference in serum urate in tart cherry juice group versus placebo group from baseline to 12 months.

  3. Change in fractional excretion of uric acid (as a percentage, %) [ Time Frame: Measured at 0, 6 and 12 months ]
    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.

  4. Change in inflammatory markers (in milligrams per litre (mg/l)) [ Time Frame: Measured at 0, 6 and 12 months ]
    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).

  5. Change in oxidative damage (in percentage (%) of tail DNA) [ Time Frame: Measured at 0, 6 and 12 months ]
    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.

  6. Change in antioxidant status (in percentage (%) of tail DNA) [ Time Frame: Measured at 0, 6 and 12 months ]
    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.

  7. Change in blood pressure (in millimetres of mercury (mmHg)) [ Time Frame: Measured at 0, 6 and 12 months ]
    Difference in brachial and central blood pressure in tart cherry juice group versus placebo group from baseline to 12 months. Measured using a Vicorder.

  8. Change in arterial stiffness (in meters per second (m/s)) [ Time Frame: Measured at 0, 6 and 12 months ]
    Difference in arterial stiffness in tart cherry juice group versus placebo group from baseline to 12 months.

  9. Change in lipid profile (in millimoles per litre (mmol/l)) [ Time Frame: Measured at 0, 6 and 12 months ]
    Difference in total cholesterol, HDL cholesterol, LDL cholesterol and triacylglycerides) in tart cherry juice group versus placebo group from baseline to 12 months.

  10. Height (in meters (m)) [ Time Frame: Measured at 0, 6 and 12 months ]
    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.

  11. Weight (in kilograms (kg)) [ Time Frame: Measured at 0, 6 and 12 months ]
    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.


Other Outcome Measures:
  1. Changes in habitual diet [ Time Frame: Measured at 0, 6 and 12 months ]
    4 day diet diaries will be used to assess any changes in habitual diet as a result of, or over the course of, the study.

  2. Changes in habitual physical activity levels [ Time Frame: Measured at 0, 6 and 12 months ]
    4 day physical activity logs will be used to assess any changes in habitual activity levels as a result of, or over the course of, the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621215


Contacts
Layout table for location contacts
Contact: Tony Lynn, PhD 0114 2252065 T.Lynn@shu.ac.uk
Contact: Margo Barker, PhD 0114 2560765 Margo.Barker@shu.ac.uk

Locations
Layout table for location information
United Kingdom
Food and Nutrition Group, Sheffield Hallam University Recruiting
Sheffield, United Kingdom, S1 1WB
Contact: Tony Lynn, PhD    0114 2252065    T.Lynn@shu.ac.uk   
Contact: Margo Barker, PhD    01142560765    Margo.Barker@shu.ac.uk   
Principal Investigator: Margo Barker, PhD         
Principal Investigator: Tony Lynn, PhD         
Sub-Investigator: Kirstie Lamb, MMedSci         
Sponsors and Collaborators
Sheffield Hallam University
Cherry Research Committee
Investigators
Layout table for investigator information
Principal Investigator: Margo Barker Sheffield Hallam University

Publications:
Layout table for additonal information
Responsible Party: Tony Lynn, Principal Lecturer (Food and Nutrition Group), Sheffield Hallam University
ClinicalTrials.gov Identifier: NCT03621215     History of Changes
Other Study ID Numbers: ER7166682
AA4736173 ( Other Grant/Funding Number: Cherry Research Committee/Cherry Marketing Institute )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tony Lynn, Sheffield Hallam University:
tart cherries
gout
cardiovascular disease risk
gout attack
gout flare
Additional relevant MeSH terms:
Layout table for MeSH terms
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases