Nutritional Supplement, Eccentric Exercise and Recovery

This study has been completed.
Sponsor:
Collaborator:
Iovate Health Sciences Research, Inc.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01444170
First received: January 30, 2008
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

The objectives of this study are to assess the effectiveness of a nutritional supplement on muscle functional recovery following induced muscle damage from high intensity resistance exercise. The investigators hypothesize that a short-term dietary supplementation will significantly improve muscle functional recovery following an intense bout of eccentric exercise compared to a placebo.


Condition Intervention Phase
Injury
Inflammation
Dietary Supplement: dicreatinol sulfate
Drug: placebo sugar pill
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Single Site Double Blind Placebo Controlled Study of the Effects of a Dietary Supplement on Muscle Recovery Following Exercise-Induced Muscle Damage

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change from baseline in self-reported symptoms and functional impairment at 10 days, 12 days, 14 days, 17 days and 20 days [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in elbow range-of-motion at 10 days, 12 days, 14 days, 17 days and 20 days [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Change from baseline in biceps brachii isometric strength at 10 days, 12 days, 14 days, 17 days and 20 days [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Change from baseline in Mechanical Pain Threshold at 10 days, 12 days, 14 days, 17 days and 20 days [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill
Placebo "sugar" pill was used as a sham control
Drug: placebo sugar pill
Experimental: dicreatinol sulfate Dietary Supplement: dicreatinol sulfate
nutritional supplement
Other Name: Sham control
Drug: placebo sugar pill

Detailed Description:

Impaired or incomplete recovery following high intensity exercise can negatively affect physical performance and delay functional progression, thereby reducing an athlete's chance of performing at his or her peak level. Athletes are constantly seeking ways to speed muscle recovery from strenuous exercise and muscle damage. Anabolic steroids are potent stimulators of muscle growth and repair and have been used extensively by athletes to hasten structural and functional recovery during peak periods of strenuous training. However, anabolic steroids are classified as banned substances by all major sports organizing committees that oversee and regulate amateur and professional athletics. In addition long-term use of anabolic steroids has known side effects that can negatively impact an athlete's health status. Dietary supplements are safe and viable alternatives that, if taken in the optimal doses, can provide positive effects on muscle growth and repair and ultimately human performance. Athletes have used dietary supplements extensively to facilitate tissue growth and repair following muscle-damaging events such as high-intensity resistance exercise and participation in contact sports. Following intense resistance exercise, an acute inflammatory response drives the repair process by synthesizing and releasing chemical mediators locally in the injured muscle. Inflammatory mediators help attract growth factors used for protein synthesis. The inflammatory response has also been shown to produce high levels of oxygen-derived free radicals that if allowed to proceed unabated, can produce further muscle damage, thus hindering the repair process. A protein-based dietary supplement, if taken in the optimal dosing schedule, may enhance the recovery process by blunting the magnitude of the acute inflammatory response and facilitating growth and repair through increased protein synthesis in damaged muscle tissue. Understanding the nutritional requirements of athletes engaged in high intensity training and competition is necessary to insure adequate recovery between exercise bouts. This will improve training and functional gains as well as act as a prophylaxis to skeletal muscle injury.

The objectives of this study are to assess the effectiveness of a nutritional supplement on muscle functional recovery following induced muscle damage from high intensity resistance exercise. This will be accomplished by evaluating baseline changes over the course of the recovery phase on severity of the symptomatic response and functional impairment in post-exercise skeletal muscle damage. The biceps brachii muscle will be targeted for this study. The investigators have established a safe and effective experimental arm curl model for inducing skeletal muscle soreness and dysfunction in human subjects using eccentric exercise to the bicep brachii muscle.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Non-smoking
  • Untrained young adult males and females (age 18-25 years)
  • Free of vitamin/mineral supplementation for six weeks prior to the study

Exclusion Criteria:

  • Pregnant or positive pregnancy test
  • Persons involved in a regular weight-training program within the last six weeks or with a prior history (within the last 6 weeks) of injury to the biceps brachii or elbow region
  • Recent history or current reported use of anti-inflammatory medication, and active weight loss > 5 kg in prior 3 months (intended or unintended)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444170

Locations
United States, Florida
Center for Exercise Science
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Iovate Health Sciences Research, Inc.
Investigators
Principal Investigator: Paul A Borsa, PhD University of Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01444170     History of Changes
Other Study ID Numbers: IRB-316-2006, UPN06050404
Study First Received: January 30, 2008
Last Updated: September 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
eccentric exercise
exercise induce muscle damage
isometric strength
range of motion
self report symptoms
mechanical pain threshold

Additional relevant MeSH terms:
Inflammation
Wounds and Injuries
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014