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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2020
Source Liverpool John Moores University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Examine the impact of the protein supplements leucine, HMB and BCAA on muscle recovery and inflammatory response following acute exercise.


Description:

Participants, both females and males, will perform an acute bout of exercise. A bout of exercise that will involve multiple drop jumps. Prior to and post exercise, functional outputs will be measured and blood will be collected to quantify the inflammatory response. The protocol will involve attending the laboratory on 6 occasions over a two week period to complete the above measures.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Drop Jumps
Perform 100 drop jumps from 40 cm height. The protocol is divided into 5 sets of 20 repetitions. Between each repetition participants get 10 seconds, and between each set 2 minutes rest. Stand on the box, drop of the box and land with feet shoulder width apart. Then immediately bend knee to approx 45 degrees and jump straight up. Throughout each jump hands are placed on hips and should not move.

Locations

Country Name City State
United Kingdom Liverpool John Moores University Liverpool Merseyside

Sponsors (1)

Lead Sponsor Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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

Outcome

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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