Effect of a Protein-enriched Drink on Muscle Function

NCT02385357 | Unknown Early Phase 1 DMC

• 1 other identifier: Puleva
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Contracture

Keywords

Muscle function; Anaerobic power; Muscle damage

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Muscle soreness of lower limbs 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

• Power output assessed with the 30sec. Wingate anaerobic test

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

• Creatine kinase

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

• Urine Creatinine

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

• Resting metabolic rate

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

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Experimental

EXPERIMENTAL

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

Dietary Supplement: Protein-enriched drink

Interventions

Protein-enriched drink 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)

Experimental

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puleva Biotech: lead
• Universidad de Granada: collaborator

Study Sites (1)

Biosearch Life

Granada, Granada, 18004, Spain

RECRUITING

MeSH Terms

Conditions

Contracture

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Study Officials

• Federico Lara, PhD

  Puleva Biotech

  STUDY DIRECTOR

Central Study Contacts

Federico Lara, PhD

CONTACT

0034958240100; Federico.LaraVilloslada@puleva.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: March 11, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

ES (1)