Ergogenic Effects of Sportlegs

NCT ID: NCT06371521

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-24
• Study Completion Date: 2024-06-01

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.

Conditions

Performance Enhancing Product Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

VO2max and Lactate Threshold

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.

Group Type: EXPERIMENTAL

Sportlegs

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Empty Capsules to serve as a placebo control

Maximal Mean Power Output

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.

Group Type: EXPERIMENTAL

Sportlegs

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Empty Capsules to serve as a placebo control

Interventions

Sportlegs

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Empty Capsules to serve as a placebo control

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Christopher Bell

OTHER

Sponsor Role: lead

Responsible Party

Christopher Bell

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Colorado State University

Fort Collins, Colorado, United States

Countries

United States

Other Identifiers

4933

Identifier Type: -

Identifier Source: org_study_id