Nutritional Supplement, Eccentric Exercise and Recovery
Primary Purpose
Injury, Inflammation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
dicreatinol sulfate
placebo sugar pill
Sponsored by

About this trial
This is an interventional prevention trial for Injury focused on measuring eccentric exercise, exercise induce muscle damage, isometric strength, range of motion, self report symptoms, mechanical pain threshold
Eligibility 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)
Sites / Locations
- Center for Exercise Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Sugar pill
dicreatinol sulfate
Arm Description
Placebo "sugar" pill was used as a sham control
Outcomes
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
Secondary Outcome Measures
Change from baseline in elbow range-of-motion at 10 days, 12 days, 14 days, 17 days and 20 days
Change from baseline in biceps brachii isometric strength at 10 days, 12 days, 14 days, 17 days and 20 days
Change from baseline in Mechanical Pain Threshold at 10 days, 12 days, 14 days, 17 days and 20 days
Full Information
NCT ID
NCT01444170
First Posted
January 30, 2008
Last Updated
July 11, 2019
Sponsor
University of Florida
Collaborators
Iovate Health Sciences International Inc
1. Study Identification
Unique Protocol Identification Number
NCT01444170
Brief Title
Nutritional Supplement, Eccentric Exercise and Recovery
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Iovate Health Sciences International Inc
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury, Inflammation
Keywords
eccentric exercise, exercise induce muscle damage, isometric strength, range of motion, self report symptoms, mechanical pain threshold
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo "sugar" pill was used as a sham control
Arm Title
dicreatinol sulfate
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
dicreatinol sulfate
Other Intervention Name(s)
Sham control
Intervention Description
nutritional supplement
Intervention Type
Drug
Intervention Name(s)
placebo sugar pill
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline in elbow range-of-motion at 10 days, 12 days, 14 days, 17 days and 20 days
Time Frame
20 days
Title
Change from baseline in biceps brachii isometric strength at 10 days, 12 days, 14 days, 17 days and 20 days
Time Frame
20 days
Title
Change from baseline in Mechanical Pain Threshold at 10 days, 12 days, 14 days, 17 days and 20 days
Time Frame
20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Borsa, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Exercise Science
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.iovate.com
Description
Iovate Health Sciences Research, Inc.
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Nutritional Supplement, Eccentric Exercise and Recovery
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