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

NCT02458599 | Completed

• 1 other identifier: 204676
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sports Nutritional Sciences

Outcome Measures

Primary Outcomes (3)

• Isometric Maximal Voluntary Contraction (MVC) Assessment

  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.

  96 hours (h)

• Counter Movement Jump (CMJ) Assessment

  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.

  96 h

• 16.1 Kilometer (km) Cycling Time Trial (TT) Assessment

  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.

  96 h

Secondary Outcomes (3)

• Serum Creatine Kinase Analysis

  96 h

• Serum C-Reactive Protein Analysis

  96 h

• Perceived Muscle Soreness Assessment

  96 h

Study Arms (3)

Test product

EXPERIMENTAL

One ready-to-drink beverage of 500 milliliter (mL) volume, containing 20 gram (g) protein will be administered orally, twice daily for four days.

Dietary Supplement: Test product

Reference product 1

ACTIVE COMPARATOR

One ready-to-drink beverage of 500 mL volume, containing 20 g carbohydrate will be administered orally, twice daily for four days.

Dietary Supplement: Reference product 1

Reference product 2

PLACEBO COMPARATOR

One ready-to-drink beverage of 500 mL volume, containing 0 g carbohydrate will be administered orally, twice daily for four days.

Dietary Supplement: Reference product 2

Interventions

Test product DIETARY_SUPPLEMENT

Whey protein hydrolysate (20 g)

Test product

Reference product 1 DIETARY_SUPPLEMENT

Iso-energetic carbohydrate (20 g)

Reference product 1

Reference product 2 DIETARY_SUPPLEMENT

Negligible energy placebo (20 g)

Reference product 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Brentford, TW8 9 DA, United Kingdom

Location

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 15, 2016

Record last verified: 2016-08

Locations

GB (1)