NCT03621215

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2021

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

1.8 years

First QC Date

July 30, 2018

Last Update Submit

June 26, 2024

Conditions

Gout FlareGout Attack

Keywords

tart cherriesgoutcardiovascular disease riskgout attackgout flare

Outcome Measures

Primary Outcomes (1)

  • 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 at 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months

Secondary Outcomes (11)

  • Change in gout flare intensity

    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))

    Measured at 0, 6 and 12 months

  • Change in fractional excretion of uric acid (as a percentage, %)

    Measured at 0, 6 and 12 months

  • Change in inflammatory markers (in milligrams per litre (mg/l))

    Measured at 0, 6 and 12 months

  • Change in oxidative damage (in percentage (%) of tail DNA)

    Measured at 0, 6 and 12 months

  • +6 more secondary outcomes

Other Outcomes (2)

  • Changes in habitual diet

    Measured at 0, 6 and 12 months

  • Changes in habitual physical activity levels

    Measured at 0, 6 and 12 months

Study Arms (2)

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.

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)

Other: Fruit-flavoured placebo drink

Interventions

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.

Tart cherry juice
Fruit-flavoured placebo drinkOTHER

Consumed daily by participants, with breakfast, for 12 months.

Fruit-flavoured placebo drink

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food and Nutrition Group, Sheffield Hallam University

Sheffield, S1 1WB, United Kingdom

Location

Related Publications (7)

  • 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.

    PMID: 23023818BACKGROUND

  • Jacob 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.

    PMID: 12771324BACKGROUND

  • Kuo 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.

    PMID: 24431399BACKGROUND

  • Cea 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.

    PMID: 21371293BACKGROUND

  • Rothenbacher 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.

    PMID: 21228059BACKGROUND

  • Dalbeth 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.

    PMID: 22275296BACKGROUND

  • Lamb 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.

    PMID: 32179562DERIVED

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Margo Barker

    Sheffield Hallam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Lecturer (Food and Nutrition Group)

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 8, 2018

Study Start

July 15, 2019

Primary Completion

April 22, 2021

Study Completion

April 22, 2021

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)