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临床试验/NCT05909475
NCT05909475已完成不适用

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

National Taiwan Sport University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Muscle composition_muscle thickness

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • With a history of cardiovascular disease, hypertension, metabolic disease, asthma or cancer diagnosed by a physician
  • 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)

结局指标

主要结局

Muscle composition_muscle thickness

时间窗: up to 6 weeks

Use muscular ultrasound (BenQ T3300) to scan muscle thickness

Isometric Mid-Thigh Pull (IMTP_RFD

时间窗: 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.

Wingate Anaerobic Test (WAnT)_relative peak power

时间窗: 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.

Wingate Anaerobic Test (WAnT)_relative mean power

时间窗: 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.

Isometric Mid-Thigh Pull (IMTP)_relative peak force

时间窗: 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.

Wingate Anaerobic Test (WAnT)_fatigue index

时间窗: 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.

The Countermovement Jump (CMJ) Test

时间窗: 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.

VO2max

时间窗: 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.

Muscle composition_fascia thickness

时间窗: up to 6 weeks

Use muscular ultrasound (BenQ T3300) to scan fascia thickness

dual-energy X-ray absorptiometry, DXA

时间窗: 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

Body composition_muscle mass

时间窗: 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

Grip strength

时间窗: 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

Body composition_body fat

时间窗: 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

次要结局

  • Safety assessment - AST(up to 6 weeks)
  • Safety assessment - ALT(up to 6 weeks)
  • Safety assessment - T-Cholesterol(up to 6 weeks)
  • Safety assessment - Uric Acid(up to 6 weeks)
  • Safety assessment - BUN(up to 6 weeks)
  • Safety assessment - Glucose(up to 6 weeks)
  • Safety assessment - Creatinine(up to 6 weeks)
  • Safety assessment - Triglycerides(up to 6 weeks)
  • Safety assessment - LDL(up to 6 weeks)
  • Safety assessment - HDL(up to 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chi-Chang Huang

Distinguished Professor

National Taiwan Sport University

研究点 (2)

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