Effect of a Protein-enriched Drink on Muscle Function (SPORTEUS)

Effect of a Protein-enriched Drink on Muscle Function Recovery Following an Acute High Intensity Exercise Bout

There is no conclusive evidence about the effect of intake of protein-enriched drink after and acute high intensity exercise bout on muscle function and damage. The investigators aimed to study the effect of a protein-enriched drink on muscle function recovery following an acute high intensity exercise bout. The present counterbalanced, crossover, and double blind study will involve a total of 12 active men.

Study Overview

• Status: Unknown
• Conditions: Contracture
• Intervention / Treatment: Dietary supplement: Protein-enriched drink

Detailed Description

Participants will run downhill (-10%) during 30 min at a intensity equivalent to 75-80% of their maximum heart rate (previously determined). After the exercise bout, participants will have either the placebo or the experimental drink. The investigators will measure muscle function and damage-related parameters right after the exercise as well as the three following days. This protocol will be repeated after a wash out period of 3 weeks, where the participants will have the other drink. The investigators will control exercise and diet three weeks before study entry, during the experimental week as the investigators as during the wash out period.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18004
    • Recruiting
    • Biosearch Life
    • Contact: Federico Lara, PhD; Phone Number: 0034958240100; Email: Federico.LaraVilloslada@puleva.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Recreational triathletes with 2 years of experience
• Maximum oxygen uptake : ≥55 ml/kg/min
• Fat mass: 8-20% measured by dual energy x-ray absorptiometry
• Not participating in another study
• Not having ergogenic aids
• Not participating in a weight loss program
• Normal electrocardiogram
• Participants must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment

Exclusion Criteria:

• History of cardiovascular disease
• Diabetes or hypertension
• Medication for hypertension, hyperlipidemia, hyperuricemia or other illness.
• Smoking
• Other significant medical conditions that are life-threatening or that can interfere with or be aggravated by exercise.
• Unwillingness to either complete the study requirements or to be randomized into control or training group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 330 ml of commercial protein-enriched drink (2.5 g/100 ml of protein)
Experimental: Experimental; 330 ml of protein-enriched drink (6 g/100 ml of protein)	Dietary supplement: Protein-enriched drink; Participants will drink 330 ml of a protein-enriched drink (6 g/ml of protein) after a high intensity exercise that induce muscle damage (30 min running downhill with a slope of -10º)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric muscle strength	Isometric muscle strength of lower limbs at 90% angle.	Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle soreness of lower limbs self-reported by a visual anagogic scale and with an algometer score.	Muscle soreness of the lower limbs will be self-reported by a visual anagogic scale and with an algometer score.	Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Power output assessed with the 30sec. Wingate anaerobic test	Power output will be assessed with the 30sec. Wingate anaerobic test.	Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Creatine kinase	Creatine kinase will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout	Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
Urine Creatinine	Concentration of creatinine in urine will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout	Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
Resting metabolic rate		Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Time limit (time that the participant is able to run 90% of his determined maximum aerobic velocity)	We will measure the time that the participant is able to run 90% of his determined maximum aerobic velocity	24hrs after protein-enriched drink

Collaborators and Investigators

• Sponsor: Puleva Biotech
• Collaborators: Universidad de Granada
• Investigators: Study Director: Federico Lara, PhD, Puleva Biotech

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 11, 2015

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Muscle function; Muscle damage; Anaerobic power
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Contracture
• Other Study ID Numbers: Puleva