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Rheumatology
Protocol
Effect of tart cherry juice on risk of gout attacks: protocol for a randomised controlled trial
  1. Kirstie Louise Lamb1,
  2. Anthony Lynn1,
  3. Jean Russell2,
  4. Margo E Barker1
  1. 1Food and Nutrition Group, Sheffield Business School, Sheffield Hallam University, Sheffield, UK
  2. 2Corporate Information and Computing Services, The University of Sheffield, Sheffield, UK
  1. Correspondence to Kirstie Louise Lamb; kirstie.lamb{at}student.shu.ac.uk

Abstract

Introduction Gout is a painful form of inflammatory arthritis associated with several comorbidities, particularly cardiovascular disease. Cherries, which are rich in anti-inflammatory and antioxidative bioactive compounds, are proposed to be efficacious in preventing and treating gout, but recommendations to patients are conflicting. Cherry consumption has been demonstrated to lower serum urate levels and inflammation in several small studies. One observational case cross-over study reported that cherry consumption was associated with reduced risk of recurrent gout attacks. This preliminary evidence requires substantiation. The proposed randomised clinical trial aims to test the effect of consumption of tart cherry juice on risk of gout attacks.

Methods and analysis This 12-month, parallel, double-blind, randomised, placebo-controlled trial will recruit 120 individuals (aged 18–80 years) with a clinical diagnosis of gout who have self-reported a gout flare in the previous year. Participants will be randomly assigned to an intervention group, which will receive Montmorency tart cherry juice daily for a 12-month period, or a corresponding placebo group, which will receive a cherry-flavoured placebo drink. The primary study outcome is change in frequency of self-reported gout attacks. Secondary outcome measures include attack intensity, serum urate concentration, fractional excretion of uric acid, biomarkers of inflammation, blood lipids and other markers of cardiovascular risk. Other secondary outcome measures will be changes in physical activity and functional status. Statistical analysis will be conducted on an intention-to-treat basis.

Ethics and dissemination This study has been granted ethical approval by the National Research Ethics Service, Yorkshire and The Humber—Leeds West Research Ethics Committee (ref: 18/SW/0262). Results of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number NCT03621215.

  • rheumatology
  • gout
  • tart cherry
  • nutrition & dietetics
  • musculoskeletal disorders
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-035108

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    Footnotes

    • Contributors AL and MEB designed the study and secured the funding. KL prepared study documents and coordinated the HRA and ethics applications. MEB and AL are joint principal investigators. KL is the study coordinator and coinvestigator. KL drafted the manuscript for publication, with input from AL, JMR and MEB. JMR advised on the study design, power calculation and statistical analysis.

    • Funding The sponsor of this research is Sheffield Hallam University, UK. This work is supported by the Cherry Marketing Institute (grant no: AA4736173), Michigan, USA. Patient recruitment to the study is supported by Yorkshire and Humber National Institute for Health Research Clinical Research Network.

    • Competing interests MEB and AL are the joint recipients of a research grant from the CMI, Michigan, USA.

    • Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Ethics approval The study protocol (V.2.0, January 2019) was reviewed and approved by Yorkshire and The Humber Leeds West REC (Ref: 18/SW/0262).

    • Provenance and peer review Not commissioned; externally peer reviewed.