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
2 other identifiers
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 30, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedJuly 15, 2019
July 1, 2019
1 year
January 30, 2008
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in self-reported symptoms and functional impairment at 10 days, 12 days, 14 days, 17 days and 20 days
20 days
Secondary Outcomes (3)
Change from baseline in elbow range-of-motion at 10 days, 12 days, 14 days, 17 days and 20 days
20 days
Change from baseline in biceps brachii isometric strength at 10 days, 12 days, 14 days, 17 days and 20 days
20 days
Change from baseline in Mechanical Pain Threshold at 10 days, 12 days, 14 days, 17 days and 20 days
20 days
Study Arms (2)
Sugar pill
PLACEBO COMPARATORPlacebo "sugar" pill was used as a sham control
dicreatinol sulfate
EXPERIMENTALInterventions
nutritional supplement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Iovate Health Sciences International Inccollaborator
Study Sites (1)
Center for Exercise Science
Gainesville, Florida, 32611, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul A Borsa, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2008
First Posted
September 30, 2011
Study Start
July 1, 2006
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
July 15, 2019
Record last verified: 2019-07