Ergogenic Effects of Sportlegs

NCT06371521 | Completed Phase 1

• 1 other identifier: 4933
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Performance Enhancing Product Use

Keywords

Exercise Performance; Ergogenic Aid; Lactate Supplement; Maximal Oxygen Uptake; Functional Threshold Power

Outcome Measures

Primary Outcomes (4)

• Maximal Oxygen Uptake

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

  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.

  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.

  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.

  30 minutes following Sportlegs or Placebo ingestion

Study Arms (2)

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.

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.

Dietary Supplement: Sportlegs; Dietary Supplement: Placebo

Interventions

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).

Maximal Mean Power Output; VO2max and Lactate Threshold

Placebo DIETARY_SUPPLEMENT

Empty Capsules to serve as a placebo control

Maximal Mean Power Output; VO2max and Lactate Threshold

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Bell: lead

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and Participants are both blinded to whether the participants will be consuming Sportlegs or Placebo during a given study visit.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, Placebo-Controlled, Double Blind Crossover Intervention

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: January 24, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)