Effect of a Protein-enriched Drink on Muscle Function

Early Phase 1UnknownNCT02385357

Puleva Biotech12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Contracture

Interventions

Protein-enriched drinkDIETARY_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)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Biosearch Life

Granada, Granada, Spain

RECRUITING

Outcomes

Primary Outcomes

Isometric muscle strength

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 Outcomes

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.

Time frame: Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink

Power output assessed with the 30sec. Wingate anaerobic test

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

Creatine kinase

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

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

Time frame: Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink

Resting metabolic rate

Time frame: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink

Time limit (time that the participant is able to run 90% of his determined maximum aerobic velocity)

Central Contacts

Federico Lara, PhD

CONTACT

0034958240100 Federico.LaraVilloslada@puleva.es

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.