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

Not Applicable

Completed

Interventions: Dietary Supplement: Reference product 1
Dietary Supplement: Test product
Dietary Supplement: Reference product 2

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Reference product 1	Reference product 1	One ready-to-drink beverage of 500 mL volume, containing 20 g carbohydrate will be administered orally, twice daily for four days.
Test product	Test product	One ready-to-drink beverage of 500 milliliter (mL) volume, containing 20 gram (g) protein will be administered orally, twice daily for four days.
Reference product 2	Reference product 2	One ready-to-drink beverage of 500 mL volume, containing 0 g carbohydrate will be administered orally, twice daily for four days.

Primary Outcome Measures

Name	Time	Method
Isometric Maximal Voluntary Contraction (MVC) Assessment	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.
Counter Movement Jump (CMJ) Assessment	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.
16.1 Kilometer (km) Cycling Time Trial (TT) Assessment	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 Outcome Measures

Name	Time	Method
Serum Creatine Kinase Analysis	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).
Serum C-Reactive Protein Analysis	96 h	Muscle inflammation will be assessed by analyzing serum high sensitivity (hs) C-reactive protein (CRP) using hs-CRP ELISA.
Perceived Muscle Soreness Assessment	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.