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Clinical Trials/NCT03337737
NCT03337737CompletedNot Applicable

The Effects of 10 Days of Extreme Endurance on Performance, Buffering Capacity During Exercise and Post Exercise Muscle Damage, Oxidative Stress and Inflammation

University of Louisiana at Lafayette0 sites16 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
16
Primary Endpoint
Human Performance

Study Overview

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.

Detailed Description

Background and Purpose:

Extreme Endurance has been studied in Europe and the data from these studies suggested that the supplement may reduce acidity and increase exercise performance. The purpose of the present investigation is to assess the total effects of Extreme Endurance during exercise. The investigation will assess the following:

Performance:

Performance will be measured as the peak wattage achieved at the lactate, and ventilator thresholds as well as the peak wattage attained during a 25 watt ramp protocol on a electronically braked cycle ergometer. During this test expired gases will be assessed breath by breath, and lactate will be measured every 2 minutes.

Buffering Capacity:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Able to participate in vigorous exercise

Exclusion Criteria

  • •Any exercise contraindication

Arms & Interventions

Placebo

Placebo Comparator

Placebo will be composed of microcrystalline cellulose in a gel capsule

Intervention: Placebo (Other)

Extreme Endurance

Active Comparator

Dietary Supplement manufactured by LifeSpan International LLC

Intervention: Extreme Endurance (Dietary Supplement)

Outcomes

Primary Outcomes

Human Performance

Time Frame: 10 days

Treadmill Exercise

Secondary Outcomes

  • Oxidative Stress(10 days)

Investigators

Sponsor
University of Louisiana at Lafayette
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Bellar

Professor and Director - School of Kinesiology

University of Louisiana at Lafayette

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