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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Sports Nutritional Sciences

Treatments: Dietary Supplement: Reference product 2; Dietary Supplement: Reference product 1; Dietary Supplement: Test product

Study type: Interventional

Funder types: Industry

Identifiers

NCT02458599

204676

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

Test product

Experimental group

Description:

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

Treatment:

Dietary Supplement: Test product

Reference product 1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Reference product 1

Reference product 2

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Reference product 2