Muscle Damage Clinical Trial
Official title:
The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise
NCT number | NCT04679519 |
Other study ID # | 16/SPS/007 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 6, 2017 |
Est. completion date | March 25, 2019 |
Verified date | December 2020 |
Source | Liverpool John Moores University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Examine the impact of the protein supplements leucine, HMB and BCAA on muscle recovery and inflammatory response following acute exercise.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 25, 2019 |
Est. primary completion date | March 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Health recreationally active males and females. Exclusion Criteria: - Asthma sufferers - People with kidney disease - People partaking in lower limb strength training - People suffering DOMS in the past 6 months - People already taking dietary supplements, other NSAIDs, or for example aspirin, alcohol, warfarin, phenytoin, methotrexate, lithium, diuretics, cyclosporine. - People with bone or soft tissue injury within last 12 months - People with gastric problems - People with hypertension - People who have had history of heart failure - People with liver disease - People with connective tissue disorders - People with Crohn's disease - People with ulcerative colitis - People with peripheral arterial disease - People with cerebrovascular disease - Elderly population - People with allergies to NSAIDs, Omega- 3 fatty acids and BCAAs. - People with depression - People with bipolar disorder - People with diabetes - Females who are pregnant - People who have HIV / AIDS |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool John Moores University | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Liverpool John Moores University |
United Kingdom,
Howatson G, Hoad M, Goodall S, Tallent J, Bell PG, French DN. Exercise-induced muscle damage is reduced in resistance-trained males by branched chain amino acids: a randomized, double-blind, placebo controlled study. J Int Soc Sports Nutr. 2012 Jul 12;9:20. doi: 10.1186/1550-2783-9-20. eCollection 2012. — View Citation
Kirby TJ, Triplett NT, Haines TL, Skinner JW, Fairbrother KR, McBride JM. Effect of leucine supplementation on indices of muscle damage following drop jumps and resistance exercise. Amino Acids. 2012 May;42(5):1987-96. doi: 10.1007/s00726-011-0928-9. Epub 2011 May 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of Creatine Kinase at baseline | Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage. | Baseline | |
Primary | Concentration of Creatine Kinase immediately after intervention. | Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage. | Immediately after intervention. | |
Primary | Concentration of Creatine Kinase at 24 hours after intervention. | Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage. | 24 hours after intervention. | |
Primary | Concentration of Creatine Kinase at 48 hours after intervention. | Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage. | 48 hours after intervention. | |
Primary | Concentration of Creatine Kinase at 7 days after intervention. | Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage. | 7 days after intervention. | |
Primary | Concentration of Creatine Kinase at 14 days after intervention. | Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage. | 14 days after intervention. | |
Primary | Number of Chair Rises at baseline | Stand and sit on chair consecutively for 30 seconds with hands placed on hips. | Baseline | |
Primary | Number of Chair Rises immediately after intervention. | Stand and sit on chair consecutively for 30 seconds with hands placed on hips. | Immediately after intervention. | |
Primary | Number of Chair Rises at 24 hours after intervention. | Stand and sit on chair consecutively for 30 seconds with hands placed on hips. | 24 hours after intervention. | |
Primary | Number of Chair Rises at 48 hours after intervention. | Stand and sit on chair consecutively for 30 seconds with hands placed on hips. | 48 hours after intervention. | |
Primary | Number of Chair Rises at 7 days after intervention. | Stand and sit on chair consecutively for 30 seconds with hands placed on hips. | 7 days after intervention. | |
Primary | Number of Chair Rises at 14 days after intervention. | Stand and sit on chair consecutively for 30 seconds with hands placed on hips. | 14 days after intervention. | |
Primary | Squat Jump height at baseline | Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally. | Baseline | |
Primary | Squat Jump height immediately after intervention. | Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally. | Immediately after intervention. | |
Primary | Squat Jump height at 24 hours after intervention. | Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally. | 24 hours after intervention. | |
Primary | Squat Jump height at 48 hours after intervention. | Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally. | 48 hours after intervention. | |
Primary | Squat Jump height at 7 days after intervention. | Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally. | 7 days after intervention. | |
Primary | Squat Jump height at 14 days after intervention. | Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally. | 14 days after intervention. | |
Primary | Range of motion at baseline. | Sit on chair, then flex and extend legs three times from 90 degrees position. | Baseline | |
Primary | Range of motion immediately after intervention. | Sit on chair, then flex and extend legs three times from 90 degrees position. | Immediately after intervention. | |
Primary | Range of motion at 24 hours after intervention. | Sit on chair, then flex and extend legs three times from 90 degrees position. | 24 hours after intervention. | |
Primary | Range of motion at 48 hours after intervention. | Sit on chair, then flex and extend legs three times from 90 degrees position. | 48 hours after intervention. | |
Primary | Range of motion at 7 days after intervention. | Sit on chair, then flex and extend legs three times from 90 degrees position. | 7 days after intervention. | |
Primary | Range of motion at 14 days after intervention. | Sit on chair, then flex and extend legs three times from 90 degrees position. | 14 days after intervention. | |
Primary | Inflammatory cytokines concentration at baseline | Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1. | Baseline | |
Primary | Inflammatory cytokines concentration at 24 hours after intervention. | Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1. | 24 hours after intervention. | |
Primary | Inflammatory cytokines concentration at 48 hours after intervention. | Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1. | 48 hours after intervention. | |
Primary | Inflammatory cytokines concentration at 7 days after intervention. | Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1. | 7 days after intervention. | |
Primary | Concentration of Lactate from baseline to immediately after intervention. | Blood drop from finger will be used to lactate. | Baseline and immediately after intervention. | |
Primary | Muscle Soreness | Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness. | Daily for 14 days. | |
Secondary | Weighed food diaries. | Fill out dietary intake on food diary, by weighing food. | Daily for 14 days. |
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