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

NCT ID: NCT02458599

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-02-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Test product

Intervention Type: DIETARY_SUPPLEMENT

Whey protein hydrolysate (20 g)

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.

Group Type: ACTIVE_COMPARATOR

Reference product 1

Intervention Type: DIETARY_SUPPLEMENT

Iso-energetic carbohydrate (20 g)

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.

Group Type: PLACEBO_COMPARATOR

Reference product 2

Intervention Type: DIETARY_SUPPLEMENT

Negligible energy placebo (20 g)

Interventions

Test product

Whey protein hydrolysate (20 g)

Intervention Type: DIETARY_SUPPLEMENT

Reference product 1

Iso-energetic carbohydrate (20 g)

Intervention Type: DIETARY_SUPPLEMENT

Reference product 2

Negligible energy placebo (20 g)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Brentford, , United Kingdom

Countries

United Kingdom

Other Identifiers

204676

Identifier Type: -

Identifier Source: org_study_id