Investigating the Efficacy of Low or High Dose Tart Cherry on Recovery From Exercise Induced Muscle Damage and Establishing Its Molecular Mechanisms of Action

NCT04725149 | Completed

• 1 other identifier: PEP-1905
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the dose-response effects of 10-day tart cherry product consumption (0, 30 ml, and 60 ml) on knee extensor isometric strength 24-h and 48-h after muscle damaging exercise and to elucidate the mechanisms of action for TC supplementation.

Conditions

Muscle Recovery

Keywords

cherry; tart cherry; Montmorency cherry; beverage; exercise; muscle recovery; muscle soreness; muscle damage; muscle function; muscle strength; muscle biopsy; mechanism; oxidative stress; inflammation; anthocyanin; polyphenol; antioxidant; cyclo-oxygenase; myotube; mygenic culture

Outcome Measures

Primary Outcomes (1)

• Isometric knee extensor strength

  Maximum voluntary contraction (MVC) as a measure of functional recovery from muscle damage. Unit of measurement is Newtons. Stronger is better.

  Changes from immediately before and immediately after muscle damaging exercise on day 8 of tart cherry supplementation to 24 hours and 48 hours after muscle damaging exercise (days 9 and 10 of supplementation).

Secondary Outcomes (15)

• Single leg eccentric and concentric isokinetic force production

  Changes from immediately before and immediately after muscle damaging exercise on day 8 of tart cherry supplementation to 24 hours and 48 hours after muscle damaging exercise (days 9 and 10 of supplementation).

• Single leg vertical jump height (SLVJ)

  Changes from immediately before and immediately after muscle damaging exercise on day 8 of tart cherry supplementation to 24 hours and 48 hours after muscle damaging exercise (days 9 and 10 of supplementation).

• Leg muscle soreness by Pressure Pain tolerance (PPT)

  Changes from immediately before and immediately after muscle damaging exercise on day 8 of tart cherry supplementation to 24 hours and 48 hours after muscle damaging exercise (days 9 and 10 of supplementation).

• Leg muscle soreness by Visual Analogue Scale (VAS)

  Changes from immediately before and immediately after muscle damaging exercise on day 8 of tart cherry supplementation to 24 hours and 48 hours after muscle damaging exercise (days 9 and 10 of supplementation).

• Leg muscle biopsy for nuclear factor k-B (NFκB)

  Changes from pre and post exercise on day 8 of tart cherry supplementation to pre-exercise on days 9 and 10 of supplementation. Biopsies are done after blood samples and before muscle soreness measures.

Study Arms (3)

0 ml tart cherry concentrate

PLACEBO COMPARATOR

Still cherry-flavored beverage, similar in appearance, taste, aroma and calories to the 30 ml and 60 ml tart cherry concentrate beverages

Other: 500 ml base solution

30 ml tart cherry concentrate

EXPERIMENTAL

"Low dose" tart cherry concentrate beverage

Other: 500 ml containing 30 ml tart cherry concentrate diluted with water and base solution

60 ml tart cherry concentrate

EXPERIMENTAL

"High dose" tart cherry concentrate beverage

Other: 500 ml containing 60 ml tart cherry concentrate diluted with water only

Interventions

500 ml base solution OTHER

Color, taste, aroma, and calorie matched water base

0 ml tart cherry concentrate

500 ml containing 30 ml tart cherry concentrate diluted with water and base solution OTHER

Montmorency cherry concentrate

30 ml tart cherry concentrate

500 ml containing 60 ml tart cherry concentrate diluted with water only OTHER

Montmorency cherry concentrate

60 ml tart cherry concentrate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male in good health
• BMI ≤ 29.9
• Recreationally active but not highly trained (Participating in sport or physical activity at least once per week for the last 6 months and lower limb resistance training ≤ 1/week) (Part B only)
• No lower limb musculoskeletal injury that prevented exercise in the last 3 months (Part B only)
• Understanding of the procedures to be undertaken as part of the study
• Willing to participate in the exercise protocols (Part B only) and follow supplementation guidelines and other instructions provided by the experimenter
• Willing to abstain from caffeine, alcohol and strenuous exercise for two 5 day periods (from 48h prior to muscle damaging exercise and throughout the follow up period; days 6-10 of the trial) for Part B, and abstain from caffeine and alcohol for two 3-day periods for Part A
• Willing to keep food diaries for the duration of each arm of the trial and avoid multiple servings per day of foods that have a high polyphenol content from a list provided.
• Willing to construct their diet for the first arm of the trial from a list of recipes provided, and to then replicate this diet during the second arm of the trial.
• Willing to wear a triaxial accelerometer throughout each arm of the trial, and during the second arm of the trial to replicate their physical activity pattern completed in the first arm of the trial.
• Willing to abstain from consumption of anti-inflammatory, analgesic medications or those with anti-coagulant effects especially NSAIDs and aspirin for 48h prior to and throughout each arm of the trial. (Part B only)
• Willing to abstain from icing or applying compression bandages to the exercised/biopsied leg (Part B only)
• Ability to provide voluntary written informed consent to participate in the study.

You may not qualify if:

• Female
• \<18y or \>40y
• BMI ≥ 30
• Lower limb musculoskeletal injury in the last 3 months (Part B only)
• Under the care of a physician
• Known health condition that could interfere with any element of the data collection protocol. Any known pulmonary, gastrointestinal (e.g., irritable bowel syndrome, Crohn's disease), kidney, cardiovascular, or metabolic diseases, blood-borne infections, or coagulopathies including deep vein thrombosis (DVT)
• Current regular consumption of nutritional/dietary supplements or previous use of any dietary supplements in the past 6 months known to have a lasting effect.
• Current use of prescription medication; including the use of an inhaler
• Non-steroidal anti-inflammatory drugs, aspirin or other analgesic medication or any anti-coagulants are prohibited during the study and for 48h prior to commencing supplementation
• Allergy/sensitivity/intolerance to cherries, any cherry derived product, or any of the additional ingredients found within the TC test products, including sensitivity to sorbitol.
• Allergy to lidocaine or other local anaesthetics. (Part B only)
• Active drug or alcohol dependency
• Current or active usage of nicotine or tobacco related products
• Participation in a clinical trial within the past 30 days or concurrently during this trial
• Participation in any PepsiCo trial within past 6 months, except that Part A participants may take part in Part B after a \>=14 day washout from Part A

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

University of Exeter Sport and Health Sciences Department

Exeter, UK, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity; Myalgia; Inflammation

Interventions

Water

Condition Hierarchy (Ancestors)

Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Joanna Bowtell, PhD

  University of Exeter, Sport and Health Sciences Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Taste-matched placebo
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Repeated measures, double-blind, counter-balanced

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 26, 2021
• Study Start: December 14, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)