Trial document




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  DRKS00008197

Trial Description

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Title

Direct endurance enhancing effect of a functional food - an EEG study.

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Trial Acronym

ENEP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Only little is known about the influence of branched chain amino acids (BCAA) on the endurance performance in athletes. Over the last 2 decades, however, some researchers have focused on the effect of these amino acids on the perception of fatigue.
We know very little about the brain mechanisms underlying fatigue perception and to investigate these we will conduct an experiment of the immediate effect of BCAAs on endurance performance in healthy cycling athletes. During cycling on an ergometer, we will measure brain activity on the scalp using electroencephalography.
Every participant is tested 3 times. During the 1st lab visit, the athlete will undergo a lactate performance test and a short practice time trial on the ergometer to minimize adaptation and learning effects for the following time trials. On the 2nd and 3rd visit endurance performance is tested in a 45 minute time trial. During the 3rd visit the athlete receives either BCAAs, placebo or nothing immediately prior to the time trial. Time trials are spaced exactly 7 days apart to control for influences of weekday and time of day on performance.
Athletes are informed, that they are participating in a randomized experiment, during which they receive either a supplement or nothing, in case they are in the control group. We will primarily measure endurance performance, fatigue perception and brain activity, as well as expectations arising from taking the supplement.
We expect that the administration of a supplement (BCAA and placebo) increases endurance performance compared with a control group. We expect this effect to manifest objectively (performance), subjectively (RPE) and centrally (EEG), however not peripherally (lactate, EKG).

15.06.2015: The expectation of performance enhancement is raised to 100%. Participants, who are not in the control group, are informed, that they will recive BCAAs.

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Brief Summary in Scientific Language

There is only limited research on the acute ergogenic effect of branched chain amino acids (BCAA) on endurance performance in athletes. However, over the past 15 years several research groups have looked at the effect of BCAAs on central fatigue.
We know very little about the underlying cortical mechanisms of central fatigue. To investigate these central mechanisms we will conduct a randomized placebo controlled double blind experiment of the acute effect of BCAAs on the endurance performance of healthy cycling athletes. During isokinetic ergometer cycling we will measure differences in electrical potentials on the scalp using electroencephalography (EEG), allowing us to infer cortical activity patterns.
Every participant is tested on 3 separate occasions. During the 1st lab visit, the athlete will undergo a lactate performance test to determine the individual anaerobic threshold. After a brief resting phase he will test the isokinetic ergometer in a short practice time trial, in order to minimize familiarization and learning effects for the following time trials. On the 2nd and 3rd visit endurance performance is tested in form of a 45 minute time trial. While the first time trial serves as a baseline, athletes receive either BCAAs, placebo or nothing during the second time trial. Time trials are spaced exactly 7 days apart to control for influences of weekday and time of day on performance.
Athletes are informed, that they are participating in a randomized experiment, during which they receive either a supplement or nothing, in case they are in the control group. We will primarily measure objective and subjective endurance performance, fatigue perception and cortical activity, as well as expectations arising from taking the supplement.
We hypothesize, that the administration of a supplement (BCAA and placebo) has an enhancing effect on endurance performance compared with a control group. We expect this effect to manifest objectively (performance), subjectively (RPE) and centrally (EEG), however not peripherally (lactate, EKG).

15.06.2015: The expectation of performance enhancement is raised to 100%. Participants, who are not in the control group, are informed, that they will recive BCAAs.

Amendment 25.11.2015: The study ended including only 20 subjects, due to timing and equipment constrains.

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Organizational Data

  •   DRKS00008197
  •   2015/06/02
  •   [---]*
  •   yes
  •   Approved
  •   157/2015BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   healthy cycling athletes
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Interventions/Observational Groups

  •   Supplement: 100g pudding (1.5g Valin, 1.3g Leucine and 1.5g Isoleucine, 6g corn-starch, 15g erythritol, 0.02g vanilin, 2 drops red food coloring, 75g Wasser)

    Single administration: The supplement is only given once immediately prior to the second time trial. Subjects are informed, that they will receive a performance enhancing BCAA supplement.
  •   Placebo: 100g pudding (4.3g chinin sulphate solution, 6g corn-starch, 15g erythritol, 0.02g vanilin, 2 drops red food coloring, 75g Wasser)

    Single administration: The placebo is only given once immediately prior to the second time trial. Subjects are informed, that they will receive a performance enhancing BCAA supplement.
  •   Control: no intervention
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Control group receives no treatment
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

1. Performance change from baseline to intervention calculated in rerference to the individual anaerobic threshhold (Watt).

2. Change in fatigue perception from baseline to intervention (rating of perceived exertion - RPE).

3. Changes in cotrical activation (EEG).

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Secondary Outcome

BMQ (Beliefs about Medicine Questionaire)
Expectations from the supplement

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/06/09
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

Minimum of 2 training sessions on the bike per weeks. Minimum of 3 competitions per season.

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Exclusion Criteria

No seious illness. No training pause of 7 days or longer in the 4 weeks prior to study participation.

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Addresses

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    • Universitätsklinikum Tübingen, Abt. Innere Medizin VI - Psychosomatische Medizin und Psychotherapie
    • Mr.  Prof. Dr.  Paul  Enck 
    • Frondsbergstrasse 23
    • 72076  Tübingen
    • Germany
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    • Abteilung Sportmedizin, Medizinische Klinik, Universitätsklinikum Tübingen
    • Mr.  Prof. Dr. med.  Andreas  Nieß 
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Abt. Innere Medizin VI - Psychosomatische Medizin und Psychotherapie
    • Ms.  MSc  Ellen  Brölz 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Abt. Innere Medizin VI - Psychosomatische Medizin und Psychotherapie
    • Ms.  MSc  Ellen  Brölz 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung Sportmedizin, Medizinische Klinik, Universitätsklinikum Tübingen
    • Mr.  Prof. Dr. med.  Andreas  Nieß 
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/11/25
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Trial Publications, Results and other Documents

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