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Exercise RecoveryNCT06332222

Recovery With Tart Cherry Supplementation Following a Marathon.

A study testing Tart Cherry in people with Exercise Recovery, run by Northumbria University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Exercise Recovery
What is being tested?
Tart Cherry
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteUnited Kingdom
Study dates
1 Apr 2023to 11 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy
  • Active

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Northumbria University

    Newcastle upon Tyne, Tyne and Wear, NE1 8ST

Other trials in United Kingdom

About this study

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
Read the detailed description

Participants

Participants were recruited from a pool of runners taking part in the Kielder marathon, Northumberland, UK. Based on a previous study that examined the effects of TC on recovery after a marathon race, it was estimated that at 0.80 power and 0.05 significance, the minimum number of participants required to detect a ≥10% group difference (SD 8%) in one of our primary outcomes, MVC, would be n = 13 per group. Thirty-eight participants were initially recruited and provided written, informed consent. Three withdrew after baseline assessment, two due to illness and one that did not want to use the intervention before the race. Therefore, 35 recreationally active runners took part in this double-blind, randomized, placebo-controlled, independent group design study. The participants were asked to maintain their habitual diet, and to fill in a short food log when they consumed foods/drinks, that were typically high in polyphenols, such as fruits \& vegetables, fruit juices, nuts and seeds, chocolate and coffee/tea. Participants were asked to refrain from strenuous exercise (other than completing training runs before the marathon) for the duration of the study and to refrain from non-steroidal anti-inflammatory or analgesic drugs, and nutritional such as protein, and vitamins. This study received ethical approval from Northumbria University Ethics Committee (reference number: 1987) and it was registered as a clinical trial with clinicaltrials.gov (TBC).

Experimental Design

The study design was an independent group design that was double blinded, randomized, and placebo controlled. Participants were assigned to two groups to consume either the TC capsules or a placebo capsule, matched for calorific content. Participants were required to attend the laboratory for a familiarisation, baseline assessment (which took place 5-6 days before the race), and 24- and 48-h post-marathon. Participants had an assessment of their functional and perceptual measures of recovery, pre-, immediately post-, 24- and 48- h post-marathon. The loading phase for the intervention ingestion commenced four days prior to the marathon and on the day of the marathon, as well as the two days following, totaling seven days.

Marathon Characteristics

The marathon took place at Kielder Water, Northumberland, UK on the 08/10/23, and consisted of an almost entirely off-road course around northern Europe's largest man-made lake, Kielder Water, with a total ascent of 613 m and total descent 616 m. The environmental conditions on the day of the race were: barometric pressure, 1023 mb; temperature, 16 C; wind speed, 7 km/h; humidity, 99%. The conditions were wet under foot and there was a mist in the air causing reduced visibility (50 m).

Treatment and Dietary Control

The participants consumed either a placebo or a TC spray-dried extract made from a variety of TC know as 'Nadwiślanka' also called Vistula Cherries (extract brand name CherryCraft®, Iprona Lana SpA, South Tyrol, Italy). The invention was consumed in the form of capsules, twice per day for a period of seven days. The supplementation period was similar to previous studies and are summarized in a recent meta-analysis. The dose increased on the day of the damaging stimuli to increase the bioavailability of phytochemicals when exercise stress and its repercussions were elevated; previous bioavailability studies have shown that increasing the dose can elevate anthocyanin and phenolic acids. The participants were required to consume a lower dose (73.5 mg of anthocyanins, according to manufacturers data) for the first four days, then consume a higher dose (132.3 mg of anthocyanins, according to manufacturers data) for the remaining three days (day of marathon protocol, 24 and 48 h post). The loading dose was determined by replicating the average reported anthocyanin content from previous studies which used powdered TC products , which was 77 mg. Then the higher dose was approximately double, similarly to the papers which have observed some differences in dose-response relationship studies.

Functional Performance and Perceptual Variables

After a familiarisation (one week prior to baseline assessments), participants were assessed for their fatigue and recovery via measures of functional performance and perceptual variables at baseline (5-6 days prior to the race), immediately post, 24- and 48-h post- marathon.

Maximal Voluntary Contraction (MVC)

MVC was measured with a portable strain gauge (MIE Medical Research Ltd., Leeds, UK). All assessments were performed with the participants seated in an upright position. After adjusting the strap to ensure a 90° knee joint angle was attained (verified with a goniometer), participants were instructed to push against the strap with maximal force for a 3 s contraction. The peak value (N) from three maximal contractions (separated by 30 s) was used for analysis. Verbal encouragement was provided for all assessments.

Counter Movement Jump (CMJ)

CMJ height was measured using an Optojump system (Microgate, Bolzano, Italy), which calculated jump height (cm) via flight time. When performing the jumps, participants were instructed to keep their hands on their hips throughout the full movement. Participants were required to descend into a squat and jump vertically with maximum effort. Three maximal efforts were performed, separated by 30 s of passive (standing) recovery, and the average value was used for data analysis.

Active Muscle Soreness

Delayed onset muscle soreness (DOMS) of the participants lower limbs was assessed via the use of a 200 mm visual analogue scale (VAS). Participants rated their lower limb soreness after performing one squat (at approximately 90° knee flexion) on a line with the far-left end point representing 'no pain' (0 mm) and the far-right end point representing 'extremely painful' (200 mm).

Passive Perceptual Wellness Variables

While seated the participants rated their feelings of soreness (passive), fatigue, energy sleepiness and readiness to train using a VAS with the far-left end point representing 'not at all' (0 mm) and the far-right end point representing 'extremely' (200 mm).

Blood Sampling Procedure

Venous blood samples were collected from a vein at antecubital fossa on four occasions (pre, immediately post, 24 and 48 h post the marathon). Samples were immediately centrifuged (3000 × g rpm) at 4°C for 15 min and the supernatant was aspirated into aliquots and then stored at -80°C until analysis. Serum was later analysed for CK and hs-CRP using an automated device (Cobas c702, Roche Diagnostics, Switzerland).

Being tested
Tart Cherry, Placebo
Keywords
Muscle Damage, Inflammation, Tart Cherry, Intervention, Marathon
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tart CherryDietary supplement

    7 day supplementation

  • PlaceboOther

    7 day supplementation

Study groups in NCT06332222
Study groupRoleWhat they receive
Vistula Tart CherryActive comparatorSupplemented with tart cherries.
Receives: Dietary Supplement: Tart Cherry
PlaceboPlacebo comparatorSupplemented with a calorie matched placebo.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Voluntary Contraction

    Leg extension MVC to measure functional recovery

    Measured: 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)
  1. Counter Movement Jump

    Jump height assessment to measure functional recovery

    Measured: 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.

  2. Active Muscle Soreness

    Visual analog scale to assess perceptual soreness, on a standard 200 mm line with the far-left end point representing 'no pain' (0 mm) and the far-right end point representing 'extremely painful' (200 mm).

    Measured: 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.

  3. Serum Concentration of High-Sensitive C-Reactive Protein

    Blood sample to measure inflammation

    Measured: 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.

  4. Serum Concentration of Creatine Kinase

    Blood sample to measure indirect muscle damage

    Measured: 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.

  5. Perceptual Measures

    Assessed via visual analog scales: soreness (passive), fatigue, energy sleepiness and readiness to train. Using a standard 200 mm line, participants rated the aforementioned perceptions, with the far-left end point representing 'not at all' (0 mm) and the far-right end point representing 'extremely' (200 mm).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start1 Apr 2023
  3. Primary completion11 Oct 2023
  4. Study completion11 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06332222
Sponsor's protocol ID
1987
Status last verified
Mar 2024
First submitted
11 Mar 2024
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27231439
  • 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.

    PubMed 19883392
  • 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.

    PubMed 33440334
  • 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.

    PubMed 34126996
  • 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.

    PubMed 32672095
  • 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.

    PubMed 34772901
  • 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.

    PubMed 27895542
  • 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.

    PubMed 30959854
  • 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.

    PubMed 31188696
  • 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

  • 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.

    PubMed 26163338
  • 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.

    PubMed 26578852
  • 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.

  • 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.

    PubMed 27267689

Questions about this trial

What is this clinical trial studying?

A study testing Tart Cherry in people with Exercise Recovery, run by Northumbria University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Voluntary Contraction (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06332222, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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