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

January 30, 2008
September 29, 2011
July 2006
July 2007   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01444170 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Nutritional Supplement, Eccentric Exercise and Recovery
A Single Site Double Blind Placebo Controlled Study of the Effects of a Dietary Supplement on Muscle Recovery Following Exercise-Induced Muscle Damage

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Injury
  • Inflammation
  • Dietary Supplement: dicreatinol sulfate
    nutritional supplement
    Other Name: Sham control
  • Drug: placebo sugar pill
  • Placebo Comparator: Sugar pill
    Placebo "sugar" pill was used as a sham control
    Intervention: Drug: placebo sugar pill
  • Experimental: dicreatinol sulfate
    Interventions:
    • Dietary Supplement: dicreatinol sulfate
    • Drug: placebo sugar pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2007
July 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01444170
IRB-316-2006, UPN06050404
Not Provided
University of Florida
University of Florida
Iovate Health Sciences Research, Inc.
Principal Investigator: Paul A Borsa, PhD University of Florida
University of Florida
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP