NCT03337737: ExtremeEnd

The Effects of 10 Days of Extreme Endurance on Performance

Completed NA Last updated 9 November 2017

What this trial tests

NA trial testing Extreme Endurance in Human Performance in 16 participants. Completed in 1 March 2017.

Timeline

1 October 2015

Primary endpoint
1 November 2016

1 March 2017

Quick facts

Lead sponsor	University of Louisiana at Lafayette
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	16
Start date	1 October 2015
Primary completion	1 November 2016
Estimated completion	1 March 2017

Drugs / interventions tested

• Extreme Endurance
• Placebo

Conditions studied

• Human Performance — all drugs for Human Performance →

Sponsor

University of Louisiana at Lafayette

Who can join

Adults 18 to 45, male only, with Human Performance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will be a double blind, placebo controlled cross over design with equal treatment and washout periods. Participants will sign an informed consent document prior to data collection and will provide descriptive information about their physical activity by filling out the Leisure and Physical Activity Survey. The participants will be 12 healthy, active college aged males. The participant will have height and weight determined via a triple beam balance with stadiometer, and their body fat% determine via a Bod Pod Gold Standard system.

After wards the participants will supplement with either Placebo or Extreme Endurance (random assignment for order) for ten days. The first 4 days will the participants will ingest four tablets in the morning and evening (8 tablets total) followed by 6 days of three tablets in the morning and evening (6 tablets total). Following the supplementation period the participant will report to the human performance lab where they will be fitted with a mask to collect expired gases and will perform a 25 watt ramp protocol on an electronically braked cycle ergometer. During this test the participant will have a short warm up period, and then a computer will automatically adjust the workload on the bike such that a slope of 25 watts/min is achieved. The test will conclude when the subject reaches volitional exhaustion. Expired gases will be assessed with a COSMED QUARK CPET system. Prior to, and every two minutes during the exercise lactate will be assessed via dermal puncture and a handheld monitor. Ten minutes after the cessation of exercise, a venipuncture will be performed in the antecubetal space and blood will be collected into a serum separator tube. This blood will be spun down in a clinical centrifuge and the serum drawn off and ammonia determined via enzymatic reaction. The remaining serum will be aliquoted and stored at -80 degrees Celsius for later analysis (muscle damage, oxidative stress, inflammation). Participants will then have a ten day rest period after which they will begin the 10 day supplementation period and exercise trial with the opposite supplement.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.