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

Primary Purpose

Contracture

Status
Unknown status
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Protein-enriched drink
Sponsored by
Puleva Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contracture focused on measuring Muscle function, Anaerobic power, Muscle damage

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Biosearch LifeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

330 ml of commercial protein-enriched drink (2.5 g/100 ml of protein)

330 ml of protein-enriched drink (6 g/100 ml of protein)

Outcomes

Primary Outcome Measures

Isometric muscle strength
Isometric muscle strength of lower limbs at 90% angle.

Secondary Outcome Measures

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.
Power output assessed with the 30sec. Wingate anaerobic test
Power output will be assessed with the 30sec. Wingate anaerobic test.
Creatine kinase
Creatine kinase will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout
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
Resting metabolic rate
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

Full Information

First Posted
February 10, 2015
Last Updated
March 10, 2015
Sponsor
Puleva Biotech
Collaborators
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT02385357
Brief Title
Effect of a Protein-enriched Drink on Muscle Function
Acronym
SPORTEUS
Official Title
Effect of a Protein-enriched Drink on Muscle Function Recovery Following an Acute High Intensity Exercise Bout
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Puleva Biotech
Collaborators
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contracture
Keywords
Muscle function, Anaerobic power, Muscle damage

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
330 ml of commercial protein-enriched drink (2.5 g/100 ml of protein)
Arm Title
Experimental
Arm Type
Experimental
Arm Description
330 ml of protein-enriched drink (6 g/100 ml of protein)
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein-enriched drink
Intervention Description
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)
Primary Outcome Measure Information:
Title
Isometric muscle strength
Description
Isometric muscle strength of lower limbs at 90% angle.
Time Frame
Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Secondary Outcome Measure Information:
Title
Muscle soreness of lower limbs self-reported by a visual anagogic scale and with an algometer score.
Description
Muscle soreness of the lower limbs will be self-reported by a visual anagogic scale and with an algometer score.
Time Frame
Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Title
Power output assessed with the 30sec. Wingate anaerobic test
Description
Power output will be assessed with the 30sec. Wingate anaerobic test.
Time Frame
Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Title
Creatine kinase
Description
Creatine kinase will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout
Time Frame
Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
Title
Urine Creatinine
Description
Concentration of creatinine in urine will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout
Time Frame
Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
Title
Resting metabolic rate
Time Frame
Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Title
Time limit (time that the participant is able to run 90% of his determined maximum aerobic velocity)
Description
We will measure the time that the participant is able to run 90% of his determined maximum aerobic velocity
Time Frame
24hrs after protein-enriched drink

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Lara, PhD
Phone
0034958240100
Email
Federico.LaraVilloslada@puleva.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Lara, PhD
Organizational Affiliation
Puleva Biotech
Official's Role
Study Director
Facility Information:
Facility Name
Biosearch Life
City
Granada
ZIP/Postal Code
18004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Lara, PhD
Phone
0034958240100
Email
Federico.LaraVilloslada@puleva.es

12. IPD Sharing Statement

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Effect of a Protein-enriched Drink on Muscle Function

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