Acute influence of a nutritional ergogenic aid on endurance performance a placebo controlled double blind trial

Transcription

1 Trial Description Title Acute influence of a nutritional ergogenic aid on endurance performance a placebo controlled double blind trial Trial Acronym NEP URL of the trial [---]* Brief Summary in Lay Language This study aims to show, that branched chain amino acids (BCAAs) have an acute effect on endurance performance. The ergogenic effect of BCAAs can be attributed to both central and peripheral processes. Only few studies have addressed the acute effect of amino acids on endurance performance so far. For this study 40 healthy, ambitious, male endurance athletes (bicyclists and triathletes) age 18 to 45 are recruited. They should conduct 3-5 bicycle training sessions per week and regularly participate in competitions. Serious illness, use of medication or training pause in the 4 weeks before the study are reasons for exclusion. Each participant will be measured on 4 days at the performance diagnostics laboratory at the Department of Sports Medicine in Tübingen. On day 1 (T1) a lactate performance test and spiro ergometry will be conducted. A step-wise protocol beginning at 40W and increasing 40W every 3 minutes will be employed. On day 2 (T2) a test time trial (30min) is performed to familiarize subjects with the isokinetic properties of the SRM bicycle ergometer. On day 3 (T3) participants will do a 45 minute isokinetic time trial (95 rpm) with the goal to achieve the highest possible power output over the entire duration. During the trial, blood samples (20 µl) are collected from the ear lobe in 10 minute intervals for lactate diagnostics. On day 4 (T4) subjects receive a BCAA, a placebo or no intervention, depending on which experimental group they were assigned to. Following the intervention they will undergo the same time trial procedure as during T3. The time trials on day 3 and 4 take place at the same time (8 or 10 am) and on the same weekday exactly 1 week apart, in order to minimize influences of natural performance fluctuations. Subjects have to come fasted on both days (no breakfast or caffeine). The primary outcome measures are subjective (RPE, questionnaires) and objective (power output and lactate) performance. T3 serves as a baseline for the dependent variables. This study employs a 2 (food vs. supplement) x 2 (verum vs. placebo) randomized factorial design with a no-treatment control group. Subjects are informed that they are participating in a randomized double blind study, with 50% chance of receiving BCAAs. Expectations regarding the ingestion of BCAAs are also measured. This study looks at the acute effect of BCAAs on endurance performance and whether the form of delivery of a supplement influences the size of its ergogenic properties. The following hypotheses are tested: (1) BCAAs have an immediate Page 1 of 7

2 effect on endurance performance during a 45 min isokinetic (95 rpm) time trial an in the subjective ratings of perceived exertion (RPE). (2) The form of delivery of the supplement influences the size of its ergogenic effect. We expect that the delivery in form of a food product (food) has a greater performance enhancing effect than in the form of a capsule (supplement). This is based on the assumption that salience (food>supplement) has a larger influence on a supplement s efficacy than conditioning (supplement>food) : We plan to increase the number of participants to N=40. Brief Summary in Scientific Language The experiment compares the ergogenic effect of food and supplements in endurance athletes. A 2x2 randomized double blind repeated measures design with a no-treatment control group will be used with the factors intervention (placebo vs. BCAAs) and form (food vs. supplement) as independent variables and motor performance measures (objective and subjective) as dependent variables. Athletes will be randomly assigned to one of 5 groups: food (F) (N=6), food placebo (FP) (N=6), supplement (S) (N=6), supplement placebo (SP) (N=6) or no treatment (control) (N=6). Athletes will be subjected to 4 test sessions. During T1, the current maximal aerobic capacity (VO2 max) and the lactate threshold will be determined using a stepwise test protocol (40W/40W/3min). In the next session, participants are familiarized with the isokinetic SRM ergometer in a 30 min practice time trial. At T3 the baseline performance time trial (T3) is taken. Exactly 7 days later at the same time of day as T3 (8am or 10am) the intervention takes place with the 45min time trial (T4). The only difference between T3 and T4 is the administration of the nutritional ergogenic aid (food or supplement) shortly before the performance test at T4. During both T3 and T4, participants cycle for 45 minutes on an isokinetic ergometer at a constant 95 rpm for maximal power output. Their performance (Watt) is measured along with physiological measurement (pulse, lactate and blood pressure) before, during and after the test. The control group, which undergoes the exact same study procedures except the administration of the nutritional ergogenic aid, is crucial to control for training effects and performance test specific learning effects. Organizational Data DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 589/2013BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen Secondary IDs Page 2 of 7

3 Health condition or Problem studied Free text: Healthy ambitious bicyclists or triathletes Interventions/Observational Groups Arm 1: FS (food supplement) - 4.3g BCAA (Branched Chain Amino Acids) in pudding; one-time application 30 min before a 45 min time trial on an isokinetic bicycle ergometer. Arm 2: CS (capsule supplement) - 4.3g BCAA (Branched Chain Amino Acids) in capsules; one-time application 30 min before a 45 min time trial on an isokinetic bicycle ergometer. Arm 3: FP (food placebo) - pudding without BCAA (Branched Chain Amino Acids); one-time application 30 min before a 45 min time trial on an isokinetic bicycle ergometer. Arm 4: CP (capsule placebo) - capsules without BCAA (Branched Chain Amino Acids); one-time application 30 min before a 45 min time trial on an isokinetic bicycle ergometer. Arm 5: C (control) - no intervention before a 45 min time trial on an isokinetic bicycle ergometer. Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: patient/subject Control: Placebo, Control group receives no treatment Purpose: Basic research/physiological study Assignment: Factorial Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome VO2 max, lactate threshold, power output and lactate values over 45min (isokinetic at 95 rpm), ratings of perceived exertion (RPE) Secondary Outcome T1: Page 3 of 7

4 German questionnaire determining expectations and experiences, current knowledge about supplements, demographic data, training schedule and nutrition. T2: HOSP (Beckmann, 2003) German questionnaire about action orientation in sports. AMS-Sport (Elbe, Wenhold & Müller, 2005) German questionnaire of performance motivation in sports. T3: SOQ (Elbe, 2001) Sport Orientiation Questionnaire by Gill und Deeter (1988). VKS (Wenhold et al., 2008) Volitional components in sports. T4: Interview regarding expectations, self-perception, performance perception, experience with the intervention. Countries of recruitment DE Locations of Recruitment University Medical Center Tübingen Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2014/02/25 Target Sample Size: 40 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Male Minimum Age: 18 Years Maximum Age: 45 Years Additional Inclusion Criteria min. 3 bike training sessions during season and regular participation in competitions Page 4 of 7

5 Exclusion criteria There should be no serious illness or use of medication during the time of the study. Also, no complete training pause in the 4 weeks immediately prior to the study. Addresses Primary Sponsor Mr. Prof. Dr. Paul Enck Frondsbergstrasse 23 Telephone: paul.enck at uni-tuebingen.de Contact for Scientific Queries Ms. MSc Ellen Kristina Broelz Frondsbergstraße 23 Telephone: ellen.broelz at med.uni-tuebingen.de Contact for Public Queries Ms. MSc Ellen Kristina Broelz Frondsbergstraße 23 Telephone: ellen.broelz at med.uni-tuebingen.de Collaborator, Other Address Abteilung Sportmedizin, Medizinische Klinik, Universitätsklinikum Tübingen Page 5 of 7

6 Collaborator, Other Address Abteilung Sportmedizin, Medizinische Klinik, Universitätsklinikum Tübingen Mr. Prof. Dr. med. Andreas Nieß Hoppe-Seyler-Str. 6 Telephone: Fax: andreas.niess at med.uni-tuebingen.de URL: Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Mr. Prof. Dr. Paul Enck Frondsbergstrasse 23 Telephone: paul.enck at uni-tuebingen.de Institutional budget, no external funding (budget of sponsor/pi) Abteilung Sportmedizin, Medizinische Klinik, Universitätsklinikum Tübingen Mr. Prof. Dr. med. Andreas Nieß Hoppe-Seyler-Str. 6 Telephone: Fax: andreas.niess at med.uni-tuebingen.de URL: Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2015/11/26 Page 6 of 7

7 Trial Publications, Results and other documents Further trial documents Rekrutierung Further trial documents Probandenaufklärung und Einverständniserklärung Paper [---]* * This entry means the parameter is not applicable or has not been set. Page 7 of 7