Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06371521 |
| Other study ID # |
4933 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
January 24, 2024 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Colorado State University |
| Contact |
Christopher Bell, PhD |
| Phone |
(970) 491-7522 |
| Email |
christopher.bell[@]colostate.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Sportlegs is a commercially available dietary/sports supplement. It is manufactured by a
local, Colorado-based company: Sport Specifics Inc. Although Sportlegs has been on the market
for approximately 20-years, very little empirical research has been completed to determine if
Sportlegs improves exercise performance. Sport Specifics Inc. has commissioned Colorado State
University to investigate the ergogenic effects of Sportlegs.
Description:
1. Study Significance: Based on published survey data, it is estimated that more than 50%
of Americans consume dietary supplements, including sport drinks. In light of widespread
use, research that evaluates the claims made by the manufacturers of supplements and
sport drinks appears to be relevant to a great number of people. Scientific evaluation
of Sportlegs will provide potential customers with an opportunity to make an informed
decision as to how they wish to spend their money.
2. Sport Specifics Inc., has had considerable commercial success selling their product,
Sportlegs. However, they recognize the potential benefit of being able to support claims
pertaining to the efficacy of their product with peer-reviewed scientific data.
Noteworthy, they also are aware of the potential risks of a scientific evaluation that
may demonstrate that their product has no effect on exercise performance, or possibly
even a negative/unfavorable effect.
3. Literature Review: To date, only one scientific study of Sportlegs has been published
(see attached). The data suggest that Sportlegs may increase blood bicarbonate
concentration (an important factor controlling blood pH) and fatigue resistance, as
described by time to exhaustion.
4. The primary ingredient in Sportlegs is lactate. Lactate is a modified form of sugar
(glucose) and is therefore a potentially important source of fuel for exercise. In this
regard, the potential for Sportlegs to improve exercise performance by making more fuel
available is intuitively appealing.
5. Historical thinking has misclassified lactic acid as metabolic waste product, and a
potential source of fatigue and muscle damage. The modern contemporary opinion is that
lactate is a gluconeogenic precursor (i.e. a source of glucose), an excellent source of
chemical energy for many organs including the heart and skeletal muscle, and it may even
have favorable clinical relevance with respect to a number of chronic diseases (see
attached review for more details). The current proposed work may contribute to the field
of Exercise Physiology by providing further confirmation of the functional benefits of
lactate and correcting previously erroneous interpretations of data.
