The Effects of 10 Days of Extreme Endurance on Performance

NCT03337737 | Completed

• 1 other identifier: FWA00000758
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Human Performance

Outcome Measures

Primary Outcomes (1)

• Human Performance

  Treadmill Exercise

  10 days

Secondary Outcomes (1)

• Oxidative Stress

  10 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be composed of microcrystalline cellulose in a gel capsule

Other: Placebo

Extreme Endurance

ACTIVE COMPARATOR

Dietary Supplement manufactured by LifeSpan International LLC

Dietary Supplement: Extreme Endurance

Interventions

Extreme Endurance DIETARY_SUPPLEMENT

Study will compare (in a crossover) placebo vs dietary supplement Extreme Endurance.

Extreme Endurance

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to participate in vigorous exercise

You may not qualify if:

• Any exercise contraindication

Sponsors & Collaborators

• University of Louisiana at Lafayette: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director - School of Kinesiology

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 9, 2017
• Study Start: October 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share