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OpenTrials
Completed

NCT Number: NCT06371521

Ergogenic Effects of Sportlegs

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Colorado State University

Fort Collins, Colorado, 80523, United States

About this study

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sportlegs

Dietary Supplement

Sportlegs contains lactate (from calcium lactate pentahydrate and magnesium lactate dihydrate), magnesium (from magnesium lactate dihydrate), calcium (from calcium lactate pentahydrate), and vitamin D (as cholecalciferol).

Placebo

Dietary Supplement

Empty Capsules to serve as a placebo control

Primary outcomes

  1. Maximal Oxygen Uptake

    Time frame: 30 minutes following Sportlegs or Placebo ingestion.

    To compare VO2max, determined during incremental stationary cycle ergometer exercise, in young healthy adults after acute ingestion of placebo and Sportlegs.

  2. Lactate Threshold

    Time frame: 30 minutes following Sportlegs or Placebo ingestion

    To compare lactate threshold, determined during incremental stationary cycle ergometer exercise, in young healthy adults after acute ingestion of placebo and Sportlegs.

  3. Rating of Perceived Exertion (RPE)

    Time frame: During the VO2max and maximal mean power tests

    To compare perceived rates of exertion, determined during stationary cycle ergometer exercise, in young healthy adults after acute ingestion of placebo and Sportlegs.

  4. Maximal sustained mean power

    Time frame: 30 minutes following Sportlegs or Placebo ingestion

    To compare the maximal mean power that can be sustained on a cycle ergometer for 20-min, in young healthy adults after acute ingestion of placebo and Sportlegs.

Sponsors and collaborators

Lead sponsor

Christopher Bell

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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