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Dietary Supplement

VO2max and Lactate Threshold for Performance Enhancing Drug Use

Phase 1

Recruiting

Research Sponsored by Christopher Bell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes following sportlegs or placebo ingestion

Awards & highlights

Study Summary

This trial is looking at a sports supplement called Sportlegs to see if it helps improve exercise performance. The supplement has been on the market for about 20 years, but there hasn't been much research

Who is the study for?

This trial is for individuals interested in the potential performance-enhancing effects of a sports supplement called Sportlegs. Specific eligibility criteria are not provided, so it's unclear who exactly can participate.Check my eligibility

What is being tested?

The study investigates whether Sportlegs, a dietary supplement made by Sport Specifics Inc., enhances exercise performance compared to a placebo. Participants will be randomly assigned to receive either the supplement or an inactive substance.See study design

What are the potential side effects?

Since this is about testing a dietary supplement, side effects may include digestive discomfort or allergic reactions; however, specific side effects are not listed in the provided information.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes following sportlegs or placebo ingestion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes following sportlegs or placebo ingestion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes following sportlegs or placebo ingestion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Lactate Threshold

Maximal Oxygen Uptake

Maximal sustained mean power

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: VO2max and Lactate ThresholdExperimental Treatment2 Interventions

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 II: Maximal Mean Power OutputExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Christopher BellLead Sponsor

8 Previous Clinical Trials

204 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of VO2max and Lactate Threshold assessments in individuals undergoing testing?

"Based on the preliminary nature of this trial, our assessment at Power rates the safety of VO2max and Lactate Threshold at 1 out of 3. This Phase 1 study has a scarcity of data to validate both safety and efficacy levels."

Answered by AI

Is the research study open to participants who are older than 60 years?

"Recruitment for this study targets individuals above 18 years of age but under the age of 30."

Answered by AI

Is this study actively seeking participants at the present time?

"Affirmative. Records on clinicaltrials.gov affirm that this investigation is actively seeking volunteers. The trial was originally disclosed on January 24, 2024 and the latest revision occurred on April 14, 2024. A total of 15 participants are sought from a single designated site."

Answered by AI

What is the current number of individuals participating in this research investigation?

"Indeed, the details on clinicaltrials.gov reveal that this research endeavor is presently in search of suitable candidates. Initially registered on January 24th, 2024, it underwent its most recent update on April 14th, 2024. The trial aims to recruit a total of fifteen participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ergogenic Effects of Sportlegs

Christopher Bell 2024. "Ergogenic Effects of Sportlegs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06371521.

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