Supplementation With GKEX Sports Probiotic Combo for Muscle Gain and Fat Loss Assessment

Probiotic Clinical Trial

Official title:

Supplementation With GKEX Sports Probiotic Combo for Muscle Gain and Fat Loss Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05909475
• Other study ID #: 22-022
• Status: Completed
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: December 24, 2022

Study information

• Verified date: June 2023
• Source: National Taiwan Sport University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 24, 2022
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• The tissues and organs of the body are functioning normally
• no disease, fatigue, or weakness
• independent and flexible activities

Exclusion Criteria:

• With a history of cardiovascular disease, hypertension, metabolic disease, asthma or cancer diagnosed by a physician
• BMI?27
• Who have taken anti-inflammatory analgesics or acute and chronic diseases within one month, etc.,
• The students and related stakeholders guided by the host of this plan
• Who have the habit of smoking and drinking
• Within two weeks Have used probiotic products in powder, capsule or tablet form (including yogurt, yogurt, Yakult and other related foods)
• Food or allergic to lactic acid bacteria products
• Have had hepatobiliary and gastrointestinal surgery within 2 years (except hernia and polypectomy)

Related Conditions & MeSH terms

• Probiotic

Intervention

Dietary Supplement:
• GKEX
GKEX group. Probiotic capsules contain 10 billion CFU (colony forming units) of GKEX, , 2 caps daily use.

Other:
• Placebo
The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

Locations

Country	Name	City	State
Taiwan	Graduate Institute of Sports Science, National Taiwan Sport University	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan Sport University	Grape King Bio Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isometric Mid-Thigh Pull (IMTP_RFD	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.	up to 6 weeks
Primary	Isometric Mid-Thigh Pull (IMTP)_relative peak force	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.	up to 6 weeks
Primary	Wingate Anaerobic Test (WAnT)_relative peak power	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.	up to 6 weeks
Primary	Wingate Anaerobic Test (WAnT)_relative mean power	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.	up to 6 weeks
Primary	Wingate Anaerobic Test (WAnT)_fatigue index	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.	up to 6 weeks
Primary	The Countermovement Jump (CMJ) Test	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.	up to 6 weeks
Primary	VO2max	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.	up to 6 weeks
Primary	Muscle composition_muscle thickness	Use muscular ultrasound (BenQ T3300) to scan muscle thickness	up to 6 weeks
Primary	Muscle composition_fascia thickness	Use muscular ultrasound (BenQ T3300) to scan fascia thickness	up to 6 weeks
Primary	dual-energy X-ray absorptiometry, DXA	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	up to 6 weeks
Primary	Body composition_body fat	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	up to 6 weeks
Primary	Body composition_muscle mass	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	up to 6 weeks
Primary	Grip strength	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	up to 6 weeks
Secondary	Safety assessment - AST	Safety is assessed function of liver such as AST (8-38 IU/L).	up to 6 weeks
Secondary	Safety assessment - ALT	Safety is assessed function of liver such as ALT (4-44 IU/L).	up to 6 weeks
Secondary	Safety assessment - T-Cholesterol	Safety is assessed function of blood lipid such as T-Cholesterol (<200 mg/dL).	up to 6 weeks
Secondary	Safety assessment - Uric Acid	Safety is assessed function of kidney such as Uric Acid (3.4-7.6 mg/dl)	up to 6 weeks
Secondary	Safety assessment - BUN	Safety is assessed function of kidney such as Bun (6-20 mg/dl)	up to 6 weeks
Secondary	Safety assessment - Creatinine	Safety is assessed function of kidney such as Creatinine (0.6-1.3 mg/dl)	up to 6 weeks
Secondary	Safety assessment - Glucose	Safety is assessed function of Glucose (70~100 mg/dL)	up to 6 weeks
Secondary	Safety assessment - Triglycerides	Safety is assessed function of blood lipid such as Triglycerides (<150 mg/dL)	up to 6 weeks
Secondary	Safety assessment - LDL	Safety is assessed function of blood lipid such as LDL (0~140mg/dl)	up to 6 weeks
Secondary	Safety assessment - HDL	Safety is assessed function of blood lipid such as HDL (>40mg/dl)	up to 6 weeks