Effect of a Protein-enriched Drink on Muscle Function

NCT ID: NCT02385357

Last Updated: 2015-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Contracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Experimental

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

Group Type EXPERIMENTAL

Protein-enriched drink

Intervention Type DIETARY_SUPPLEMENT

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)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role collaborator

Puleva Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Federico Lara, PhD

Role: STUDY_DIRECTOR

Puleva Biotech

Locations

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Biosearch Life

Granada, Granada, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Federico Lara, PhD

Role: CONTACT

0034958240100

Facility Contacts

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Federico Lara, PhD

Role: primary

0034958240100

Other Identifiers

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Puleva

Identifier Type: -

Identifier Source: org_study_id

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