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

Sports Nutritional Sciences Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458599
• Other study ID #: 204676
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: August 12, 2016
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sports Nutritional Sciences

Intervention

Dietary Supplement:
• Test product
Whey protein hydrolysate (20 g)
• Reference product 1
Iso-energetic carbohydrate (20 g)
• Reference product 2
Negligible energy placebo (20 g)

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Brentford

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No
Primary	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	No
Secondary	Serum Creatine Kinase Analysis	Muscle damage will be assessed by analyzing serum creatine kinase (CK) using CK N-Acetyl-L Cysteine (NAC)-activated Enzyme Linked Immunosorbent Assay (ELISA).	96 h	No
Secondary	Serum C-Reactive Protein Analysis	Muscle inflammation will be assessed by analyzing serum high sensitivity (hs) C-reactive protein (CRP) using hs-CRP ELISA.	96 h	No
Secondary	Perceived Muscle Soreness Assessment	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.	96 h	No