Clinical trial NCT02385357: Effect of a Protein-enriched Drink on Muscle Function
Official title: Effect of a Protein-enriched Drink on Muscle Function Recovery Following an Acute High Intensity Exercise Bout
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Contracture
Keywords: Muscle function
Anaerobic power
Muscle damage
Lead sponsor: Puleva Biotech
Sponsor class: INDUSTRY
Collaborators: name: Universidad de Granada
First posted: 2015-03-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Isometric muscle strength
timeFrame: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Secondary outcomes:
measure: Muscle soreness of lower limbs self-reported by a visual anagogic scale and with an algometer score.
timeFrame: Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
measure: Power output assessed with the 30sec. Wingate anaerobic test
timeFrame: Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
measure: Creatine kinase
timeFrame: Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
measure: Urine Creatinine
timeFrame: Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
measure: Resting metabolic rate
timeFrame: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
measure: Time limit (time that the participant is able to run 90% of his determined maximum aerobic velocity)
timeFrame: 24hrs after protein-enriched drink
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Biosearch Life
Study officials:
affiliation: Puleva Biotech
name: Federico Lara, PhD
role: STUDY_DIRECTOR
References: