Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06332222
Other study ID # 1987
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date October 11, 2023

Study information

Verified date March 2024
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date October 11, 2023
Est. primary completion date October 11, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy - Active Exclusion Criteria: - Food allergy - Smokers - Cardiovascular/gastrointestinal/thyroid/renal disease - Musculoskeletal injury

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Tart Cherry
7 day supplementation
Other:
Placebo
7 day supplementation

Locations

Country Name City State
United Kingdom Northumbria University Newcastle Upon Tyne Tyne And Wear

Sponsors (2)

Lead Sponsor Collaborator
Northumbria University Iprona Lana SpA

Country where clinical trial is conducted

United Kingdom, 

References & Publications (14)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Counter Movement Jump Jump height assessment 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 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). 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 Serum Concentration of High-Sensitive C-Reactive Protein Blood sample to measure inflammation 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 Serum Concentration of Creatine Kinase Blood sample to measure indirect muscle damage 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 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). 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.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05428228 - Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults N/A
Completed NCT04959006 - Investigating a Natural Antioxidant Food Product on Oxidative Stress in Recreationally Active Participants N/A
Not yet recruiting NCT06436781 - Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population Phase 3
Withdrawn NCT05924035 - HBOT and Exercise Recovery N/A
Completed NCT00975390 - Muscle Glycogen Synthesis When Caffeine and Protein is Co-Ingested With Carbohydrates N/A
Completed NCT05428761 - Clinical Trial to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults N/A