NCT06332222

Brief Summary

The goal of this clinical trial is to compare recovery in healthy, active runners. The main questions it aimed to answer were whether 7 day supplementation with Vistula TC attenuated:

  • muscle function
  • inflammation
  • soreness following a marathon run. Participants will either consume a spray-dried tart cherry supplement or a calorie-matched placebo-control for 7 days, and complete a marathon. Participants will perform functional tests, be assessed for their perceptual recovery and markers of inflammation and muscle damage via:
  • maximal voluntary contractions
  • counter movement jumps
  • visual analog scales to assess soreness
  • blood samples

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 11, 2024

Last Update Submit

March 18, 2024

Conditions

Exercise Recovery

Keywords

Muscle DamageInflammationTart CherryInterventionMarathon

Outcome Measures

Primary Outcomes (1)

  • Maximal Voluntary Contraction

    Leg extension MVC to measure functional recovery

    Measurements were taken on 4 separate occasions. Once at baseline, before supplementation began, which took place 5-6 days before the race. The measurement was taken again immediately post the marathon and again 24 and 48 hours post marathon.

Secondary Outcomes (5)

  • Counter Movement Jump

    Measurements were taken on 4 separate occasions. Once at baseline, before supplementation began, which took place 5-6 days before the race. The measurement was taken again immediately post the marathon and again 24 and 48 hours post marathon.

  • Active Muscle Soreness

    Measurements were taken on 4 separate occasions. Once at baseline, before supplementation began, which took place 5-6 days before the race. The measurement was taken again immediately post the marathon and again 24 and 48 hours post marathon.

  • Serum Concentration of High-Sensitive C-Reactive Protein

    Measurements were taken on 4 separate occasions. Once at baseline, before supplementation began, which took place 5-6 days before the race. The measurement was taken again immediately post the marathon and again 24 and 48 hours post marathon.

  • Serum Concentration of Creatine Kinase

    Measurements were taken on 4 separate occasions. Once at baseline, before supplementation began, which took place 5-6 days before the race. The measurement was taken again immediately post the marathon and again 24 and 48 hours post marathon.

  • Perceptual Measures

    Measurements were taken on 4 separate occasions. Once at baseline, before supplementation began, which took place 5-6 days before the race. The measurement was taken again immediately post the marathon and again 24 and 48 hours post marathon.

Study Arms (2)

Vistula Tart Cherry

ACTIVE COMPARATOR

Supplemented with tart cherries.

Dietary Supplement: Tart Cherry

Placebo

PLACEBO COMPARATOR

Supplemented with a calorie matched placebo.

Other: Placebo

Interventions

Tart CherryDIETARY_SUPPLEMENT

7 day supplementation

Vistula Tart Cherry
PlaceboOTHER

7 day supplementation

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy
  • Active

You may not qualify if:

  • Food allergy
  • Smokers
  • Cardiovascular/gastrointestinal/thyroid/renal disease
  • Musculoskeletal injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (14)

  • Levers K, Dalton R, Galvan E, O'Connor A, Goodenough C, Simbo S, Mertens-Talcott SU, Rasmussen C, Greenwood M, Riechman S, Crouse S, Kreider RB. Effects of powdered Montmorency tart cherry supplementation on acute endurance exercise performance in aerobically trained individuals. J Int Soc Sports Nutr. 2016 May 26;13:22. doi: 10.1186/s12970-016-0133-z. eCollection 2016.

    PMID: 27231439BACKGROUND

  • Howatson G, McHugh MP, Hill JA, Brouner J, Jewell AP, van Someren KA, Shave RE, Howatson SA. Influence of tart cherry juice on indices of recovery following marathon running. Scand J Med Sci Sports. 2010 Dec;20(6):843-52. doi: 10.1111/j.1600-0838.2009.01005.x.

    PMID: 19883392BACKGROUND

  • Hill JA, Keane KM, Quinlan R, Howatson G. Tart Cherry Supplementation and Recovery From Strenuous Exercise: A Systematic Review and Meta-Analysis. Int J Sport Nutr Exerc Metab. 2021 Mar 1;31(2):154-167. doi: 10.1123/ijsnem.2020-0145. Epub 2021 Jan 13.

    PMID: 33440334BACKGROUND

  • Hooper DR, Orange T, Gruber MT, Darakjian AA, Conway KL, Hausenblas HA. Broad Spectrum Polyphenol Supplementation from Tart Cherry Extract on Markers of Recovery from Intense Resistance Exercise. J Int Soc Sports Nutr. 2021 Jun 14;18(1):47. doi: 10.1186/s12970-021-00449-x.

    PMID: 34126996BACKGROUND

  • Morehen JC, Clarke J, Batsford J, Barrow S, Brown AD, Stewart CE, Morton JP, Close GL. Montmorency tart cherry juice does not reduce markers of muscle soreness, function and inflammation following professional male rugby League match-play. Eur J Sport Sci. 2021 Jul;21(7):1003-1012. doi: 10.1080/17461391.2020.1797181. Epub 2020 Aug 6.

    PMID: 32672095BACKGROUND

  • Wangdi JT, O'Leary MF, Kelly VG, Jackman SR, Tang JCY, Dutton J, Bowtell JL. Tart Cherry Supplement Enhances Skeletal Muscle Glutathione Peroxidase Expression and Functional Recovery after Muscle Damage. Med Sci Sports Exerc. 2022 Apr 1;54(4):609-621. doi: 10.1249/MSS.0000000000002827.

    PMID: 34772901BACKGROUND

  • McCormick R, Peeling P, Binnie M, Dawson B, Sim M. Effect of tart cherry juice on recovery and next day performance in well-trained Water Polo players. J Int Soc Sports Nutr. 2016 Nov 14;13:41. doi: 10.1186/s12970-016-0151-x. eCollection 2016.

    PMID: 27895542BACKGROUND

  • Kupusarevic J, McShane K, Clifford T. Cherry Gel Supplementation Does Not Attenuate Subjective Muscle Soreness or Alter Wellbeing Following a Match in a Team of Professional Rugby Union players: A Pilot Study. Sports (Basel). 2019 Apr 5;7(4):84. doi: 10.3390/sports7040084.

    PMID: 30959854BACKGROUND

  • Abbott W, Brashill C, Brett A, Clifford T. Tart Cherry Juice: No Effect on Muscle Function Loss or Muscle Soreness in Professional Soccer Players After a Match. Int J Sports Physiol Perform. 2020 Feb 1;15(2):249-254. doi: 10.1123/ijspp.2019-0221. Epub 2019 Oct 28.

    PMID: 31188696BACKGROUND

  • 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. doi:10.1016/j.jff.2014.09.004

    BACKGROUND

  • Keane KM, Bell PG, Lodge JK, Constantinou CL, Jenkinson SE, Bass R, Howatson G. Phytochemical uptake following human consumption of Montmorency tart cherry (L. Prunus cerasus) and influence of phenolic acids on vascular smooth muscle cells in vitro. Eur J Nutr. 2016 Jun;55(4):1695-705. doi: 10.1007/s00394-015-0988-9. Epub 2015 Jul 11.

    PMID: 26163338BACKGROUND

  • Levers K, Dalton R, Galvan E, Goodenough C, O'Connor A, Simbo S, Barringer N, Mertens-Talcott SU, Rasmussen C, Greenwood M, Riechman S, Crouse S, Kreider RB. Effects of powdered Montmorency tart cherry supplementation on an acute bout of intense lower body strength exercise in resistance trained males. J Int Soc Sports Nutr. 2015 Nov 16;12:41. doi: 10.1186/s12970-015-0102-y. eCollection 2015.

    PMID: 26578852BACKGROUND

  • Kastello, G., Bretl, M., Clark, E., Delvaux, C., Hoeppner, J., McNea, L., & Strauss, J. (2014). The effect of cherry supplementation on Exercise induced oxidative stress. International Journal of Food Sciences and Nutrition, 1(1), 20-26.

    BACKGROUND

  • Clifford T, Bell O, West DJ, Howatson G, Stevenson EJ. Antioxidant-rich beetroot juice does not adversely affect acute neuromuscular adaptation following eccentric exercise. J Sports Sci. 2017 Apr;35(8):812-819. doi: 10.1080/02640414.2016.1192670. Epub 2016 Jun 7.

    PMID: 27267689BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Glyn Howatson

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Glyn Howatson

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 27, 2024

Study Start

April 1, 2023

Primary Completion

October 11, 2023

Study Completion

October 11, 2023

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)