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Completed

NCT Number: NCT02458599

Efficacy Study of Protein Supplementation in Attenuating the Decline in Performance After Strenuous Concurrent Exercise

This study is designed to investigate whether protein supplementation can improve recovery of muscle function following a strenuous combination of both endurance and resistance exercise. It will specifically investigate the effect of protein supplementation on the recovery of strength, power and endurance exercise performance, along with measures of damage and inflammation of the muscle.

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Key information

Conditions

Sports Nutritional Sciences

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Brentford, TW8 9 DA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary informed consent form and has received signed and dated copy of the informed consent form
  • Male participants; age between 18 to 35 years, inclusive
  • Well trained endurance cyclist (competing at a minimum of Category 3 road-racing/estimated 10 mile TT of <23 minutes), with a training history >1 year
  • Good general and mental health

Exclusion criteria

  • Currently taking any nutritional supplements, polyphenols or beta-blockers, Non-steroidal anti-inflammatory drugs (NSAIDs), recreational drugs
  • Known or suspected intolerance or hypersensitivity to the study material or any of their stated ingredients
  • Allergy to milk or wheat products
  • Heart or any other medical condition that may contra-indicate participants from taking part in high intensity or exhaustive physical activity
  • Previous participation in this study; another clinical study or receipt of an investigational drug within 30 days of the screening visit; participation in another study involving a protocol to elicit Exercise-Induced Muscle Damage (EIMD) within 6 months of the screening visit

Treatment and study plan

Test product

Dietary Supplement

Whey protein hydrolysate (20 g)

Reference product 1

Dietary Supplement

Iso-energetic carbohydrate (20 g)

Reference product 2

Dietary Supplement

Negligible energy placebo (20 g)

Primary outcomes

  1. Isometric Maximal Voluntary Contraction (MVC) Assessment

    Time frame: 96 hours (h)

    Maximum voluntary isometric contraction (MVIC) will be assessed at the knee during a leg extension movement using an isokinetic dynamometer. MVIC will be used to assess strength. Participants will perform the exercise using the dominant leg at a knee joint angle of 70º three times, with a contraction of 3 seconds (s) on each occasion (each contraction separated by 60 s rest). The peak force (measured in Newton) generated across the three repetitions will be recorded.

  2. Counter Movement Jump (CMJ) Assessment

    Time frame: 96 h

    Power will be assessed using counter-movement jump. Participants will place their hands on their hips, descend rapidly to ~90º knee joint angle, and then jump as high as possible using a counter-movement. Three jumps will be performed (each jump separated by 60 s rest) and the peak vertical jump height (measured in centimeters) will be recorded.

  3. 16.1 Kilometer (km) Cycling Time Trial (TT) Assessment

    Time frame: 96 h

    The 16.1 km cycling TT assessment will be performed on a cycling ergometer. Participants will be required to complete a distance of 16.1 km in as short a time as possible, while being blinded to time elapsed.

Secondary outcomes

  1. Serum Creatine Kinase Analysis

    Time frame: 96 h

    Muscle damage will be assessed by analyzing serum creatine kinase (CK) using CK N-Acetyl-L Cysteine (NAC)-activated Enzyme Linked Immunosorbent Assay (ELISA).

  2. Serum C-Reactive Protein Analysis

    Time frame: 96 h

    Muscle inflammation will be assessed by analyzing serum high sensitivity (hs) C-reactive protein (CRP) using hs-CRP ELISA.

  3. Perceived Muscle Soreness Assessment

    Time frame: 96 h

    Perceived muscle soreness will be measured on a 200 mm visual analogue scale (VAS) where 0 mm= no pain and 200 mm= unbearably painful. Participants will be required to hold a fixed squat position (90º knee joint angle) while perceived muscle soreness is rated.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Evaluate the Effects of Protein Supplementation in Attenuating the Decline in Performance Following Strenuous Concurrent Exercise

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2015
Registry last updated
Aug 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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