The Effects of 10 Days of Extreme Endurance on Performance
Condition: Human Performance
Study type: Interventional

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:

      In the human body decreased inter-muscular pH can be quantified through changes in the amount
      of expired CO2 and increases in serum ammonia (highly correlated with changes in pH
      associated with high intensity exercise) and lactate measured in whole blood during the
      exercise.

      Muscle Damage:

      Post exercise stress and damage to muscle tissue can be quantified by examining the blood for
      substances normally contained in the muscle tissue only. For this study both creatine kinase
      and lactate dehydrogenase will be assessed, both have been used as markers of muscle damage
      in a plethora of scientific publications.

      Oxidative Stress:

      During exercise free radicals are generated, which a supplement such as Extreme Endurance can
      potentially reduce. For this study 8OHdG will be measured, this is a marker of oxidative
      damage to DNA caused by free radicals produced during exercise.

      Inflammation:

      Exercise produces a well documented inflammatory response. To examine the effects of Extreme
      Endurance on inflammation a custom multiplex assay will be run that will measure IL-2, IL-6,
      TNF alpha and C-reactive protein. These are all common markers for inflammation.

      Research Questions:

        1. Does Extreme Endurance improve performance and increase power output during a graded
           cycling protocol compared to placebo?

        2. Does Extreme Endurance improve buffering capacity during a graded cycling protocol
           compared to placebo?

        3. Does Extreme Endurance reduce muscle damage caused by a graded cycling protocol compared
           to placebo?

        4. Does Extreme Endurance reduce oxidative stress caused by a graded cycling protocol
           compared to placebo?

        5. Does Extreme Endurance reduce inflammation caused by a graded cycling protocol compared
           to placebo?

      Methodology

      Study Design

      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 physical activity history by
      filling out the Leisure and Physical Activity Survey. The participants will be 16 healthy,
      active college aged males. The participants will have height and weight determined via a
      triple beam balance with stadiometer, and 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
      participants will report to the human performance lab where a mask will be fitted 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 participant 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.

      Immunoassays

      At the conclusion of data collection, serum aliquots will be thawed and analyzed via
      colormetric or chemiluminescent immunoassays.

      Timeframe

      Mar 2016 - Begin Subject Recruitment

      Sept 2016 - Finish Data collection
    

Intervention name(s): Extreme Endurance; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Study will compare (in a crossover) placebo vs dietary supplement Extreme Endurance.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other