Performance Enhancing Product UsePhase 1NCT06371521
Ergogenic Effects of Sportlegs
A Phase 1 study testing Sportlegs in people with Performance Enhancing Product Use, run by Christopher Bell at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance Enhancing Product Use
- What is being tested?
- Sportlegs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 1 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-30 years (inclusive)
- Minimum of 150 minutes/week of moderate intensity endurance exercise during the previous 12-months.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
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.
Read the detailed description
- 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.
- Conditions
- Performance Enhancing Product Use
- Being tested
- Sportlegs, Placebo
- Keywords
- Exercise Performance, Ergogenic Aid, Lactate Supplement, Maximal Oxygen Uptake, Functional Threshold Power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SportlegsDietary 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).
PlaceboDietary supplement
Empty Capsules to serve as a placebo control
| Study group | Role | What they receive |
|---|---|---|
| VO2max and Lactate Threshold | Experimental | Participants will ingest either Sportlegs or placebo.
The Sportlegs (and placebo) will be ingested as dietary capsules taken with water.
30-minutes after ingestion, the VO2max and lactate threshold testing will commence. This will involve a graded exercise test on a cycle ergometer to volitional fatigue. Heart rate and gas exchange will be measured prior to and throughout the exercise test. Blood will be sampled approximately every 60-seconds from a venous catheter placed in a hand or wrist vein, or from a finger using a lancet and cappillary tube. The amount of blood to be sampled is up to ~2-3 ml per sample, totalling less than 40 mL per lab visit. The blood will be immediately analyzed for lactate concentration using an automated analyzer. Ratings of Perceived Exertion will be recorded every ~2 minutes.
VO2max and lactate threshold are considered important predictors of exercise performance. Receives: Dietary Supplement: Sportlegs; Dietary Supplement: Placebo |
| Maximal Mean Power Output | Experimental | The Sportlegs (and placebo) will be ingested as dietary capsules taken with water.
30-minutes after ingestion, participants will begin the FTP20 test. Following a brief, standardized warm-up, participants will exercise on a stationary cycle ergometer at the highest intensity they are able to sustain for 20-minutes. This is akin to a "time-trial" where cyclists cover as greater distance as possible during a pre-determined period of time. During the FTP20 test, work rate will be monitored and recorded, as will heart rate (monitored continuously but only recorded every 5-minutes via short range telemetry or ECG). Rating of perceived exertion will also be assessed and recorded every 5-minutes.
The FTP20 test is considered an important predictor of exercise performance. Receives: Dietary Supplement: Sportlegs; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen Uptake
To compare VO2max, determined during incremental stationary cycle ergometer exercise, in young healthy adults after acute ingestion of placebo and Sportlegs.
Measured: 30 minutes following Sportlegs or Placebo ingestion.
Lactate Threshold
To compare lactate threshold, determined during incremental stationary cycle ergometer exercise, in young healthy adults after acute ingestion of placebo and Sportlegs.
Measured: 30 minutes following Sportlegs or Placebo ingestion
Rating of Perceived Exertion (RPE)
To compare perceived rates of exertion, determined during stationary cycle ergometer exercise, in young healthy adults after acute ingestion of placebo and Sportlegs.
Measured: During the VO2max and maximal mean power tests
Maximal sustained mean power
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.
Measured: 30 minutes following Sportlegs or Placebo ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start24 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance Enhancing Product UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Placebo-Controlled, Double Blind Crossover Intervention
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Bell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Bell, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371521
- Sponsor's protocol ID
- 4933
- Status last verified
- Jul 2024
- First submitted
- 14 Apr 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergogenic Effects of Sportlegs
- ClinicalTrials.gov ID
- NCT06371521
- Acronym / sponsor ID
- 4933
- Conditions
- Performance Enhancing Product Use
- Keywords
- Exercise Performance, Ergogenic Aid, Lactate Supplement, Maximal Oxygen Uptake, Functional Threshold Power
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Christopher BellUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Placebo-Controlled, Double Blind Crossover Intervention
| Arm | Type | Receives |
|---|---|---|
| VO2max and Lactate Threshold | Experimental | Dietary Supplement: Sportlegs, Dietary Supplement: PlaceboParticipants will ingest either Sportlegs or placebo. The Sportlegs (and placebo) will be ingested as dietary capsules taken with water. 30-minutes after ingestion, the VO2max and lactate threshold testing will commence. This will involve a graded exercise test on a cycle ergometer to volitional fatigue. Heart rate and gas exchange will be measured prior to and throughout the exercise test. Blood will be sampled approximately every 60-seconds from a venous catheter placed in a hand or wrist vein, or from a finger using a lancet and cappillary tube. The amount of blood to be sampled is up to ~2-3 ml per sample, totalling less than 40 mL per lab visit. The blood will be immediately analyzed for lactate concentration using an automated analyzer. Ratings of Perceived Exertion will be recorded every ~2 minutes. VO2max and lactate threshold are considered important predictors of exercise performance. |
| Maximal Mean Power Output | Experimental | Dietary Supplement: Sportlegs, Dietary Supplement: PlaceboThe Sportlegs (and placebo) will be ingested as dietary capsules taken with water. 30-minutes after ingestion, participants will begin the FTP20 test. Following a brief, standardized warm-up, participants will exercise on a stationary cycle ergometer at the highest intensity they are able to sustain for 20-minutes. This is akin to a "time-trial" where cyclists cover as greater distance as possible during a pre-determined period of time. During the FTP20 test, work rate will be monitored and recorded, as will heart rate (monitored continuously but only recorded every 5-minutes via short range telemetry or ECG). Rating of perceived exertion will also be assessed and recorded every 5-minutes. The FTP20 test is considered an important predictor of exercise performance. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-30 years (inclusive)
- Minimum of 150 minutes/week of moderate intensity endurance exercise during the previous 12-months.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SportlegsSportlegs 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). | Dietary supplement | Maximal Mean Power Output, VO2max and Lactate Threshold |
| PlaceboEmpty Capsules to serve as a placebo control | Dietary supplement | Maximal Mean Power Output, VO2max and Lactate Threshold |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sportlegs in people with Performance Enhancing Product Use, run by Christopher Bell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Oxygen Uptake (time frame: 30 minutes following Sportlegs or Placebo ingestion.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.