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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05981820
Other study ID # AnkaraUSport
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2022
Est. completion date January 15, 2023

Study information

Verified date July 2023
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Creatine is an ergogenic aid with positive effects on muscle and performance. The aim of the study was to determine whether there is a difference between the effects of creatine supplementation taken together with Wingate-based HIIT on anaerobic power, leg strength, heart rate variability and body composition. In the study, Wingate-based HIIT program was applied three days a week for six weeks. Anaerobic power (Wingate anaerobic power test), heart rate variability (Polar H10 chest band), leg strength (back and leg dynamometer) and body composition (PlusAvis 333) measurements of the participants were made 1 week before the training program started and the week after the training program ended. Twenty physically active adult men aged 18-30 were voluntarily included for the study. Participants were divided into two groups: Wingate-based HIIT with creatine supplementation (K-HIIT) and Wingate-based HIIT only (HIIT). As a result of the analysis, it was seen that creatine supplementation taken together with wingate-based HIIT had an effect and increased on the anaerobic power parameters, peak power, average power and minimum power values, and leg strength. In addition, it was determined that heart rate variability parameters improved heart rate (HR, beat/min) and low frequency (LF, ms2) values, but did not cause any change in body composition. Comparing and investigating the effects of different HIIT methods on anaerobic power, leg strength, heart rate variability and body composition will increase the generalizability of the study.


Description:

Despite the time-efficiency of HIIT in inducing chronic physiological adaptation, it depleted phosphocreatine stores in the muscle and decrease power output. It has been observed that high-intensity exercise performance increases with the increase of intramuscular phosphocreatine. It is thought that with creatine supplementation, the rate of phosphocreatine resynthesis and mitochondrial transfer of ATP to the cytoplasm may increase. This suggests that performing HIIT with creatine supplementation will provide further improvement. Therefore, the purpose of this study to compare the effectiveness of HIIT with creatine supplement compared to HIIT only. We hypothesized that creatine supplementation intake with wingate-based HIIT will positively affect power capacity and performance-related parameters. The research will be carried out using experimental research design, one of the quantitative research methods, to measure the variables and determine the relationship between dependent and independent variables. Anaerobic power, heart rate variability, leg strength, and body composition measurements of the participants will be made 1 week before the training program started and the week after the training program ended. The G*power software was utilized in order to determine the appropriate sample size. It has been reported that a minimum of 12 participants, 6 in each group, should be included in the study (alpha value = 0.05, 1-beta value = 0.80, and effect size = 1.6). Measurement of tests and the Wingate-based HIIT program will be conducted in the Performance Laboratory of the Faculty of Sports Sciences of Ankara University. Twenty physically active adult men aged 18-30 years, who had no history of medical and did not use drugs or ergogenic aids, will be recruited voluntarily. The ethics committee approval for the study methodology was obtained from the Ethics Committee of Ankara University Rectorate (Number: E-56786525-050.04.04/378028 Decision Number: 2022/02) and it will be carried out in compliance with the Declaration of Helsinki's principles. Written inform consents which explain the study to the participant and any right and risk will be obtained prior to data collection. Permission for the research to be carried out in the Performance Laboratory of the Faculty of Sport Sciences of Ankara University will be obtained from the Deanery of the Faculty of Sport Sciences of Ankara University. Participants will be divided into two groups as those who will perform Wingate-based HIIT with creatine (C-HIIT) (age: 21,78 ± 1,79 years; height: 179.56 ± 8.26 cm; weight: 76.86 ± 10.66 kg) and those who will perform only Wingate-based HIIT (HIIT) (age: 20.167 ± 0,98 years; height: 172.33 ± 9,88 cm ; weight: 66.53 ± 9.51kg ). Out of twenty potential participants, only 15 participants agreed to participate in the study (HIIT=6, C-HIIT=9) and 5 dropped out because of sport injuries that occured before the study process. IBM SPSS 24.0 program (SPSS Inc., Chicago, IL, USA) will be used to statistically analyze the data obtained in the study. First of all, the distribution of the data will be evaluated to determine the test used to compare the data as parametric or non-parametric. This normality distribution assessment will be tested with Shapiro Wilk, as both groups had less than 50 participants. Determination of the mean difference in within-group statistics will be performed with Paired Sample t-Test in data with normal distribution and with Wilcoxon test in data where it is not normal. Groups will be expressed as mean ± standard error. American Psychological Association (APA) 6.0 style will be used to report statistical differences. The alpha value will be accepted as 0.05 in all statistical analysis. This study aimed to determine whether there was a difference in the effects of taking creatine supplementation with Wingate-based HIIT on anaerobic power, leg strength, heart rate variability and body composition. The limitation of the current research is that the study will be carried out with a single gender. In future studies on the subject, the number of participants can be increased, female participants can be included in the research and it can be examined whether there is a difference between genders and to increase the generalizability of the study, the effects of different HIIT methods on anaerobic power, leg strength, heart rate variability and body composition can be compared by investigating. In addition, the trial period may be extended as longer periods are needed to see clearer changes in HRV.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 15, 2023
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - having no health and communication problem - using no drugs or ergogenic aids - being physically active adult men aged 18-30 years Exclusion Criteria: - using any drugs or ergogenic aids - having any musculoskeletal problem

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Creatine
To observe the effects of creatine in the study, 10 g of creatine supplementation was taken only on training days during the study period. Participants used 10 g of creatine monohydrate by dissolved in 200 ml of water. Creatine supplementation was taken in two doses of five grams, 30 minutes before and after training.
Other:
HIIT training
In the first three weeks: Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes Wingate-based HIIT: HIIT 4 sets of 12x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set Cool-down: 4 minutes of passive rest between sets In the last three weeks: Warm-up: Warm-up at 70 rpm for 4 minutes, including 2-3 seconds of maximal sprint at 1.30 and 2.30 minutes Wingate-based HIIT: HIIT 5 sets of 20x15 seconds of maximal repetitions with 15 seconds of passive rest between reps in each set Cool-down: 4 minutes of passive rest between sets

Locations

Country Name City State
Turkey Ankara University Spor Bilimleri Fakultesi Golbasi Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wingate anaerobic power test The Wingate anaerobic power test will be performed using a bicycle ergometer.First, a four-minute warm-up protocol with a bicycle ergometer at 60-80 rpm pedal speed and 50 W workload will be applied. Weights of 7.5% kilograms of their body weight for each participant will be placed on the pan of the bicycle ergometer and anaerobic power testing will be initiated. When they reach the pedal speed to 150 rpm, the test will start. Their maximal effort during 30-seconds will be collected. The Wingate software will be used in which the program set up with the ergometers. Information about the relevant power parameters during the test will be transmitted to the software program on the computer. All power parameters such as both absolute and relative peak power, minimum power, average power etc. will be calculated by the software program automatically. two months
Primary Leg strength Back and leg dynamometer (Takei-Back & Lift, Japan) will be used to measure leg strength. Participants will be placed their feet on the dynamometer stand. The legs will be bent at 15 angles, the body slightly forward, and the back straight. The participants will pull the dynamometer bar, which they grasped with their hands, using only their legs, without changing their current position, until the knees will be extended. Participants will repeat this trial twice, and the best value for each participant will be recorded. two months
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