- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07472244
Does the Development of the Repeated Bout Effect Depend on Oxidative Stress and Inflammation? (ANTI-RBE)
Eccentric exercise, particularly when novel and strenuous, can cause soreness and inflammation, impairing subsequent exercise performance. These performance decrements are attributable to oxidative stress and inflammation. Interestingly, a single bout of eccentric exercise can confer protective effects, ameliorating the negative consequences in subsequent bouts. This is termed the repeated bout effect (RBE), which would be of interest to athletes considering the detrimental effects of strenuous eccentric exercise. Athletes regularly consume supplements in hope of attenuating the performance decrements after strenuous eccentric exercise
. However, considering the dose-response relationship between the initial performance decrement and the magnitude of the RBE , supplements may diminish the obtainment of the RBE. This notion remains untested, and so the proposed project is a double-blind, placebo-controlled, parallel group study aiming to assess the effects of acute vitamin C and ibuprofen supplementation on the development of the RBE. These two supplements were chosen as they are most frequently and successfully used in the literature to target oxidative stress (vitamin C) and inflammation (ibuprofen). Additionally, these doses (and the timing of supplements) were chosen to mimic protocols reporting beneficial effects
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bath, United Kingdom
- Recruiting
- University of Bath
-
Contact:
- Max Davis
- Phone Number: 07950449960
- Email: md959@bath.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 - 45 years of age
- BMI 18.5 - 29.9 kg/m2
- Able to perform 20-minutes of bench stepping exercise
- Capable and willing to provide consent (oral and written)
Exclusion Criteria:
- Familiarised with bench stepping exercise procedures
- Not cleared for exercise by health questionnaires or physical activity readiness questionnaire
- Participants exhibiting any alteration in clinical inflammation parameters due to other cause
- Participants currently being prescribed any anti-inflammatory medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Vitamin C and Non-steroidal anti-inflammatory drug
|
1,000 mg Vitamin C and 400 mg non-steroidal anti-inflammatory drug every 8-h for 48-h
|
|
Placebo Comparator: Control
Identical Placebo
|
Identical maltodextrin tablet.
Appearance and weight matched
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Function
Time Frame: Baseline and post exercise (2 hours, 1 day, 7 day)
|
Jump height calculated through flight time
|
Baseline and post exercise (2 hours, 1 day, 7 day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Function
Time Frame: Baseline and post exercise (2 hours, 1 day, 7 day)
|
Peak power quantified using a Keiser Leg Press
|
Baseline and post exercise (2 hours, 1 day, 7 day)
|
|
Muscle Function
Time Frame: Baseline and post exercise (2 hours, 1 day, 7 day)
|
Peak force quantified using a Keiser Leg Press
|
Baseline and post exercise (2 hours, 1 day, 7 day)
|
|
Muscle Function
Time Frame: Baseline and post exercise (2 hours, 1 day, 7 day)
|
Peak velocity quantified using a Keiser Leg Press
|
Baseline and post exercise (2 hours, 1 day, 7 day)
|
|
Creatine Kinase
Time Frame: Baseline and immediately, 1-h (hour)-, 2-h-, 24-h-,and 48-hours-post-exercise
|
Plasma Creatine Kinase
|
Baseline and immediately, 1-h (hour)-, 2-h-, 24-h-,and 48-hours-post-exercise
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11104-14846
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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