The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise

• ClinicalTrials.gov Identifier: NCT04679519
• Recruitment Status: Completed
• First Posted: December 22, 2020
• Last Update Posted: January 6, 2021
• Sponsor: Liverpool John Moores University
• Information provided by (Responsible Party): Liverpool John Moores University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Muscle Damage	Other: Drop Jumps	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised control study with four groups, one control and three protein supplements.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise
• Actual Study Start Date: March 6, 2017
• Actual Primary Completion Date: March 25, 2019
• Actual Study Completion Date: March 25, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control; Control group that was not given a supplement.	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.
Experimental: BCAA; Supplement group that was given Branched Chain Amino Acids (BCAA).	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.
Experimental: Leucine; Supplement group that was given Leucine.	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.
Experimental: HMB; Supplement group that was given β-Hydroxy β-methylbutyric acid (HMB)	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.

Outcome Measures

Primary Outcome Measures :

1. Concentration of Creatine Kinase at baseline [ Time Frame: Baseline ]
   Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
2. Concentration of Creatine Kinase immediately after intervention. [ Time Frame: Immediately after intervention. ]
   Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
3. Concentration of Creatine Kinase at 24 hours after intervention. [ Time Frame: 24 hours after intervention. ]
   Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
4. Concentration of Creatine Kinase at 48 hours after intervention. [ Time Frame: 48 hours after intervention. ]
   Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
5. Concentration of Creatine Kinase at 7 days after intervention. [ Time Frame: 7 days after intervention. ]
   Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
6. Concentration of Creatine Kinase at 14 days after intervention. [ Time Frame: 14 days after intervention. ]
   Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage.
7. Number of Chair Rises at baseline [ Time Frame: Baseline ]
   Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
8. Number of Chair Rises immediately after intervention. [ Time Frame: Immediately after intervention. ]
   Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
9. Number of Chair Rises at 24 hours after intervention. [ Time Frame: 24 hours after intervention. ]
   Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
10. Number of Chair Rises at 48 hours after intervention. [ Time Frame: 48 hours after intervention. ]
    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
11. Number of Chair Rises at 7 days after intervention. [ Time Frame: 7 days after intervention. ]
    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
12. Number of Chair Rises at 14 days after intervention. [ Time Frame: 14 days after intervention. ]
    Stand and sit on chair consecutively for 30 seconds with hands placed on hips.
13. Squat Jump height at baseline [ Time Frame: Baseline ]
    Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.
14. Squat Jump height immediately after intervention. [ Time Frame: Immediately after intervention. ]
    Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally.
15. Squat Jump height at 24 hours after intervention. [ Time Frame: 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.
16. Squat Jump height at 48 hours after intervention. [ Time Frame: 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.
17. Squat Jump height at 7 days after intervention. [ Time Frame: 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.
18. Squat Jump height at 14 days after intervention. [ Time Frame: 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.
19. Range of motion at baseline. [ Time Frame: Baseline ]
    Sit on chair, then flex and extend legs three times from 90 degrees position.
20. Range of motion immediately after intervention. [ Time Frame: Immediately after intervention. ]
    Sit on chair, then flex and extend legs three times from 90 degrees position.
21. Range of motion at 24 hours after intervention. [ Time Frame: 24 hours after intervention. ]
    Sit on chair, then flex and extend legs three times from 90 degrees position.
22. Range of motion at 48 hours after intervention. [ Time Frame: 48 hours after intervention. ]
    Sit on chair, then flex and extend legs three times from 90 degrees position.
23. Range of motion at 7 days after intervention. [ Time Frame: 7 days after intervention. ]
    Sit on chair, then flex and extend legs three times from 90 degrees position.
24. Range of motion at 14 days after intervention. [ Time Frame: 14 days after intervention. ]
    Sit on chair, then flex and extend legs three times from 90 degrees position.
25. Inflammatory cytokines concentration at baseline [ Time Frame: 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.
26. Inflammatory cytokines concentration at 24 hours after intervention. [ Time Frame: 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.
27. Inflammatory cytokines concentration at 48 hours after intervention. [ Time Frame: 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.
28. Inflammatory cytokines concentration at 7 days after intervention. [ Time Frame: 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.
29. Concentration of Lactate from baseline to immediately after intervention. [ Time Frame: Baseline and immediately after intervention. ]
    Blood drop from finger will be used to lactate.
30. Muscle Soreness [ Time Frame: Daily for 14 days. ]
    Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness.

Secondary Outcome Measures :

1. Weighed food diaries. [ Time Frame: Daily for 14 days. ]
   Fill out dietary intake on food diary, by weighing food.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United Kingdom

Liverpool John Moores University

Liverpool, Merseyside, United Kingdom, L3 3AF

Sponsors and Collaborators

Liverpool John Moores University

More Information

Publications:

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.

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.

• Responsible Party: Liverpool John Moores University
• ClinicalTrials.gov Identifier: NCT04679519
• Other Study ID Numbers: 16/SPS/007
• First Posted: December 22, 2020
• Last Update Posted: January 6, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Participant data to be published.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No