Acute Effects of Tart Cherry on Uric Acid and Biomarkers of CVD Risk in Healthy Individuals

NCT04960527 | Completed

• 1 other identifier: ER9199256
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to provide evidence as to whether consumption of tart cherry juice can reduce the risk of gout and cardiovascular disease (CVD) in an acute context. The proposed study is a 2-way cross-over, randomised, placebo-controlled trial and aims to answer the following research questions:

1. 1.What effect does a single 30mL serving of tart cherry concentrate have on serum uric acid and urinary excretion of uric acid in healthy individuals, when compared with water?
2. 2.What effect does a single 30mL serving of tart cherry concentrate have on markers of cardiovascular disease risk and oxidative stress in healthy individuals, when compared with water?

Conditions

Uric Acid; Cardiovascular Diseases; Gout

Outcome Measures

Primary Outcomes (1)

• Change in serum urate (in millimoles per litre (mmol/l)

  Difference in serum urate in tart cherry juice arm versus water arm from baseline to 24 hours post-consumption of drink. Measured using a commercial fluorometric/colorimetric urate assay kit.

  Measured at baseline, 1, 2, 3, 5 and 24 hours post-consumption of test drink

Secondary Outcomes (7)

• Change in urinary urate (mmol/l)

  Measured from samples collected at baseline and between 0-2 hours, 2-4 hours, 4-5 hours, 5-8 hours, 8-11 hours and 11-24 hours

• Change in urinary creatinine (mmol/l)

  Measured from samples collected at baseline and between 0-2 hours, 2-4 hours, 4-5 hours, 5-8 hours, 8-11 hours and 11-24 hours

• Change in serum creatinine (mmol/l)

  Measured at baseline, 1, 2, 3, 5 and 24 hours post-consumption of test drink

• Change in c reactive protein (in milligrams per litre (mg/l)

  Measured at baseline, 2 and 5 hours post-consumption of test drink

• Change in blood pressure (in millimetres of mercury (mmHg))

  Measured at baseline, 1, 2, 3, 5, and 24-hours post-consumption of test drink

Other Outcomes (2)

• Avoidance of strenuous physical activity

  Measured from 72-hours prior to the study until 24-hours post-consumption of test drink

• Adherence to a low-polyphenolic diet

  Measured from 48-hours prior to the study until 24-hours post-consumption of test drink

Study Arms (2)

Tart cherry juice

EXPERIMENTAL

30 mL tart cherry concentrate (CherryActive, UK, 100% Montmorency) diluted with 220 mL water (totalling 250 mL). According to available manufacturers data, this is equivalent to consuming 90-100 fresh cherries.

Dietary Supplement: Tart cherry juice

Water

OTHER

250 mL water (neutral control)

Other: Water

Interventions

Tart cherry juice DIETARY_SUPPLEMENT

250 mL tart cherry juice (30 mL tart cherry concentrate \[CherryActive, UK\] diluted with 220 mL water) is consumed on a single occasion by each participant. This will be consumed immediately following the baseline measurements one laboratory visit.

Tart cherry juice

Water OTHER

250 mL water is consumed on a single occasion by each participant. This will be consumed immediately following the baseline measurements one laboratory visit.

Water

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or over
• able and willing to participate in the study and provide written informed consent

You may not qualify if:

• current smoker
• any known food allergies/intolerances
• history of medical conditions, including gastrointestinal disease, severe renal impairment (estimated glomerular filtration rate of \<30ml/min) or renal disease, cardiovascular disease, diabetes (type 1 or type 2) and gout

Sponsors & Collaborators

• Sheffield Hallam University: lead

Study Sites (1)

Food and Nutrition Group, Sheffield Hallam University

Sheffield, S1 1WB, United Kingdom

Location

Related Publications (5)

• 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: 12771324 BACKGROUND

• White SJ, Carran EL, Reynolds AN, Haszard JJ, Venn BJ. The effects of apples and apple juice on acute plasma uric acid concentration: a randomized controlled trial. Am J Clin Nutr. 2018 Feb 1;107(2):165-172. doi: 10.1093/ajcn/nqx059.

  PMID: 29529161 BACKGROUND

• Lynn A, Mathew S, Moore CT, Russell J, Robinson E, Soumpasi V, Barker ME. Effect of a tart cherry juice supplement on arterial stiffness and inflammation in healthy adults: a randomised controlled trial. Plant Foods Hum Nutr. 2014 Jun;69(2):122-7. doi: 10.1007/s11130-014-0409-x.

  PMID: 24570273 BACKGROUND

• Chai SC , Davis K , Wright RS , Kuczmarski MF , Zhang Z . Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. Food Funct. 2018 Jun 20;9(6):3185-3194. doi: 10.1039/c8fo00468d.

  PMID: 29862410 BACKGROUND

• Bell, P. G., Gaze, D. C., Davison, G. W., George, T. W., Scotter, M. J., & Howatson, G. (2014). Montmorency tart cherry (Prunus cerasus L.) concentrate lowers uric acid, independent of plasma cyanidin-3-O-glucosiderutinoside. Journal of Functional Foods, 11, 82-90.

  BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Gout

Interventions

Water

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Tony Lynn, PhD

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Lecturer Ethics Lead

Model Details: 2-way crossover, randomised controlled trial. Participants will be allocated to consume tart cherry juice or a neutral water control on separate occasions. The order of this allocation will be randomised.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 14, 2021
• Study Start: July 10, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

GB (1)