Status:
COMPLETED
Investigating the Efficacy of Low or High Dose Tart Cherry on Recovery From Exercise Induced Muscle Damage and Establishing Its Molecular Mechanisms of Action
Lead Sponsor:
PepsiCo Global R&D
Conditions:
Muscle Recovery
Eligibility:
MALE
18-40 years
Phase:
NA
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...
Detailed Description
Montmorency cherry supplementation has been shown to exert antioxidant and anti-inflammatory effects that can be beneficial for improving recovery from exercise. However, the investigator is currently...
Eligibility Criteria
Inclusion
- Male in good health
- 18-40y
- 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.
Exclusion
- Female
- \<18y or \>40y
- BMI ≥ 30
- Inactive or well-trained (see inclusion criteria) (Part B only)
- 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
- Inability to provide written informed consent
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04725149
Start Date
December 14 2020
End Date
December 15 2022
Last Update
April 3 2023
Active Locations (1)
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1
University of Exeter Sport and Health Sciences Department
Exeter, UK, United Kingdom, EX1 2LU