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

NCT04679519 | Completed

• 1 other identifier: 16/SPS/007
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Damage

Outcome Measures

Primary Outcomes (30)

• 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

• 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.

• 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.

• 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.

• 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.

• 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.

• Number of Chair Rises at baseline

  Stand and sit on chair consecutively for 30 seconds with hands placed on hips.

  Baseline

• Number of Chair Rises immediately after intervention.

  Stand and sit on chair consecutively for 30 seconds with hands placed on hips.

  Immediately after intervention.

• 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.

• 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.

• 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.

• 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.

• 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

• 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.

• 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.

• 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.

• 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.

• 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.

• Range of motion at baseline.

  Sit on chair, then flex and extend legs three times from 90 degrees position.

  Baseline

• Range of motion immediately after intervention.

  Sit on chair, then flex and extend legs three times from 90 degrees position.

  Immediately after intervention.

• 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.

• 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.

• 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.

• 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.

• 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

• 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.

• 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.

• 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.

• Concentration of Lactate from baseline to immediately after intervention.

  Blood drop from finger will be used to lactate.

  Baseline and immediately after intervention.

• Muscle Soreness

  Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness.

  Daily for 14 days.

Secondary Outcomes (1)

• Weighed food diaries.

  Daily for 14 days.

Study Arms (4)

Control

ACTIVE COMPARATOR

Control group that was not given a supplement.

Other: Drop Jumps

BCAA

EXPERIMENTAL

Supplement group that was given Branched Chain Amino Acids (BCAA).

Other: Drop Jumps

Leucine

EXPERIMENTAL

Supplement group that was given Leucine.

Other: Drop Jumps

HMB

EXPERIMENTAL

Supplement group that was given β-Hydroxy β-methylbutyric acid (HMB)

Other: Drop Jumps

Interventions

Drop Jumps OTHER

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.

BCAA; Control; HMB; Leucine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Health recreationally active males and females.

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

Related 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.

  PMID: 22569039 BACKGROUND

• 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.

  PMID: 21562819 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised control study with four groups, one control and three protein supplements.

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 22, 2020
• Study Start: March 6, 2017
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: January 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

GB (1)