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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02458599
Enrollment
24
Registered
2015-06-01
Start date
2015-06-30
Completion date
2016-02-29
Last updated
2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sports Nutritional Sciences

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.

Interventions

DIETARY_SUPPLEMENTTest product

Whey protein hydrolysate (20 g)

DIETARY_SUPPLEMENTReference product 1

Iso-energetic carbohydrate (20 g)

DIETARY_SUPPLEMENTReference product 2

Negligible energy placebo (20 g)

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Isometric Maximal Voluntary Contraction (MVC) Assessment96 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.
Counter Movement Jump (CMJ) Assessment96 hPower 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.
16.1 Kilometer (km) Cycling Time Trial (TT) Assessment96 hThe 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

MeasureTime frameDescription
Serum Creatine Kinase Analysis96 hMuscle damage will be assessed by analyzing serum creatine kinase (CK) using CK N-Acetyl-L Cysteine (NAC)-activated Enzyme Linked Immunosorbent Assay (ELISA).
Serum C-Reactive Protein Analysis96 hMuscle inflammation will be assessed by analyzing serum high sensitivity (hs) C-reactive protein (CRP) using hs-CRP ELISA.
Perceived Muscle Soreness Assessment96 hPerceived 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026