Graduate Institute of Sports Science, National Taiwan Sport University
Taoyuan, 33301, Taiwan
NCT Number: NCT05909475
Objective: To discuss the "GKEX Sports Probiotics Combination (hereinafter referred to as GKEX)", a product commissioned by Grape King Biotechnology Co., Ltd., and its effects on increasing muscle mass, muscle strength, physical performance and improving body composition when combined with resistance exercise training. Method: The experiment adopts a double-blind design. After screening, 52 subjects (20 males and 32 females) were randomly divided into two groups, each with 10 males and 16 females: (1) placebo without GKEX probiotics Capsule group (Placebo) (2 capsules/day), (2) GKEX group (GKEX) (1x1010 CFU/capsule, 2 capsules/day). All subjects received daily supplementation samples for 6 weeks and received resistance exercise training three times a week. Before the intervention and 6 weeks after the intervention, the diet evaluation, systemic and resistive body composition, muscle ultrasound, muscle strength, maximum oxygen uptake, explosive power, anaerobic power, etc. were detected respectively.
Looking for future studies?
Notify Me20 year–39 year
All sexes
Interventional
Not applicable
Taoyuan, 33301, Taiwan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GKEX group. Probiotic capsules contain 10 billion CFU (colony forming units) of GKEX, , 2 caps daily use.
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.
Time frame: up to 6 weeks
Customized IMTP test equipment and two force plates (type 9287BA, Kistler Instruments AG, Winterthur, Switzerland) were used. All participants stood with their feet the same width apart, and the rod was placed between the thighs, with the torso upright, the spine neutral, and the knee and hip angles at 140°, to familiarize the participants with the IMPT test method. The average absolute peak rate of force development (RFD) parameters were recorded.
Time frame: up to 6 weeks
Customized IMTP test equipment and two force plates (type 9287BA, Kistler Instruments AG, Winterthur, Switzerland) were used. All participants stood with their feet the same width apart, and the rod was placed between the thighs, with the torso upright, the spine neutral, and the knee and hip angles at 140°, to familiarize the participants with the IMPT test method. The average absolute peak rate of force development (RFD) parameters were recorded.
Time frame: up to 6 weeks
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative peak power parameters were recorded.
Time frame: up to 6 weeks
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative mean power parameters were recorded.
Time frame: up to 6 weeks
After a standard warm-up, all subjects were assessed with the classical WAnT on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average fatigue index parameters were recorded.
Time frame: up to 6 weeks
The CMJ test is a practical, effective, reliable, and simple method of measuring lower limb strength, which is related to the maximum speed, strength and explosive force of the lower limbs. For this test, participants stood on the Kistler force measurement platform (9260AA, Kistler Co., Ltd., Switzerland) on both feet and performed to inspection. During the test, they were asked to put their hands on their hips and remain on the platform. After that, they were asked to squat down until the knees bent 90 degrees and then to immediately jump as high as possible. The average power (MF), were recorded during the jump. Each participant repeated the test 3 times, and CMJ data were obtained at the designated points. The instrument was calibrated for each individual's weight.
Time frame: up to 6 weeks
To evaluate the maximum oxygen consumption and exercise performance, we used a treadmill (Pulsar, h/p/cosmos, Nussdorf-Traunstein, Germany) and an automatic breathing analyzer (Vmax 29c, Sensor Medics, Yorba Linda, CA, USA). In addition, a polar heart rate device was used to monitor the heart rate (HR). The speed range of the treadmill was set to 7.2 km/h and increased by 1.8 km/h every 2 min until fatigue, according to Bruce's protocol. When the breathing exchange rate (the volume ratio of carbon dioxide produced to oxygen consumed, VCO2/VO2) was higher than 1.10 and reached the maximum heart rate (maximum heart rate = 220 - age), oxygen consumption was considered to be maximum. The three highest VO2max peak were averaged to obtain the VO2max values of the individual volunteers.
Time frame: up to 6 weeks
Use muscular ultrasound (BenQ T3300) to scan muscle thickness
Time frame: up to 6 weeks
Use muscular ultrasound (BenQ T3300) to scan fascia thickness
Time frame: up to 6 weeks
A non-invasive dual-energy X-ray absorptive bone density testing room (Lunar iDXA, GE Healthcare, Chicago, IL, USA) was used for systemic body composition and bone density measurements. The subject was required to lie flat on the test bed, with their body at the center line, and their limbs within the detection range. Two different energy X-rays were used to scan the inspected part, then the scintillation detector received the X-rays that had penetrated the inspected part, and analyzed the obtained muscle mass
Time frame: up to 6 weeks
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The body fat were meansure
Time frame: up to 6 weeks
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The muscle mass were meansure
Time frame: up to 6 weeks
Use the armed grip machine (T.K.K.5401, Takei Scientific Instruments Co.,Ltd, Niigata, Japan) to measure, hold each of the left and right hands three times until they are weak, and record the maximum value
Time frame: up to 6 weeks
Safety is assessed function of liver such as AST (8-38 IU/L).
Time frame: up to 6 weeks
Safety is assessed function of liver such as ALT (4-44 IU/L).
Time frame: up to 6 weeks
Safety is assessed function of blood lipid such as T-Cholesterol (<200 mg/dL).
Time frame: up to 6 weeks
Safety is assessed function of kidney such as Uric Acid (3.4-7.6 mg/dl)
Time frame: up to 6 weeks
Safety is assessed function of kidney such as Bun (6-20 mg/dl)
Time frame: up to 6 weeks
Safety is assessed function of kidney such as Creatinine (0.6-1.3 mg/dl)
Time frame: up to 6 weeks
Safety is assessed function of Glucose (70~100 mg/dL)
Time frame: up to 6 weeks
Safety is assessed function of blood lipid such as Triglycerides (<150 mg/dL)
Time frame: up to 6 weeks
Safety is assessed function of blood lipid such as LDL (0~140mg/dl)
Time frame: up to 6 weeks
Safety is assessed function of blood lipid such as HDL (>40mg/dl)
National Taiwan Sport University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07114341
Ergogenic Athletic Performance, Ergogenic Support
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07094191
Exercise Metabolism, Fat Metabolism
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07464899
Athlete Assessment, Behavior
San Vicent del Raspeig, Alicante, Spain
View Trial DetailsNCT07389837
Behavior, Carbohydrate Intolerance
Montreal, Quebec, Canada
View Trial Details