Effect of a Protein-enriched Drink on Muscle Function

Early Phase 1

• Conditions: Contracture

• Registration Number: NCT02385357
• Lead Sponsor: Puleva Biotech

Brief Summary

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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-10
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Biosearch Life; 🇪🇸 Granada, Spain