Clinical trial NCT06371521: Ergogenic Effects of Sportlegs
Official title: Ergogenic Effects of Sportlegs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Performance Enhancing Product Use
Keywords: Exercise Performance
Ergogenic Aid
Lactate Supplement
Maximal Oxygen Uptake
Functional Threshold Power
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Placebo-Controlled, Double Blind Crossover Intervention
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18-30 years (inclusive)
* Minimum of 150 minutes/week of moderate intensity endurance exercise during the previous 12-months.

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Use of Sportlegs within the previous 4-weeks
* Use of magnesium supplements within the previous 4-weeks
* Unwillingness to abstain from the use of other potentially ergogenic dietary supplements throughout the duration of participation in the study
* Inability or unwillingness to perform vigorous cycle ergometer exercise

Primary outcomes:
measure: Maximal Oxygen Uptake
timeFrame: 30 minutes following Sportlegs or Placebo ingestion.
measure: Lactate Threshold
timeFrame: 30 minutes following Sportlegs or Placebo ingestion
measure: Rating of Perceived Exertion (RPE)
timeFrame: During the VO2max and maximal mean power tests
measure: Maximal sustained mean power
timeFrame: 30 minutes following Sportlegs or Placebo ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References: