Effect of a Protein-enriched Drink on Muscle Function

Contracture Clinical Trial

— SPORTEUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385357
• Other study ID #: Puleva
• Status: Recruiting
• Phase: Phase 0
• First received: February 10, 2015
• Last updated: March 10, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Puleva Biotech
• Contact: Federico Lara, PhD
• Phone: 0034958240100
• Email: Federico.LaraVilloslada[@]puleva.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contracture

Intervention

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)

Locations

Country	Name	City	State
Spain	Biosearch Life	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Puleva Biotech	Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Resting metabolic rate		Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink	No
Secondary	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	No