Clinical trial NCT05909475: Supplementation With GKEX Sports Probiotic Combo for Muscle Gain and Fat Loss Assessment
Official title: Supplementation With GKEX Sports Probiotic Combo for Muscle Gain and Fat Loss Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport Nutrition
Probiotic
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
Collaborators: name: Grape King Bio Ltd.
First posted: 2023-06-18
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Isometric Mid-Thigh Pull (IMTP_RFD
timeFrame: up to 6 weeks
measure: Isometric Mid-Thigh Pull (IMTP)_relative peak force
timeFrame: up to 6 weeks
measure: Wingate Anaerobic Test (WAnT)_relative peak power
timeFrame: up to 6 weeks
measure: Wingate Anaerobic Test (WAnT)_relative mean power
timeFrame: up to 6 weeks
measure: Wingate Anaerobic Test (WAnT)_fatigue index
timeFrame: up to 6 weeks
measure: The Countermovement Jump (CMJ) Test
timeFrame: up to 6 weeks
measure: VO2max
timeFrame: up to 6 weeks
measure: Muscle composition_muscle thickness
timeFrame: up to 6 weeks
measure: Muscle composition_fascia thickness
timeFrame: up to 6 weeks
measure: dual-energy X-ray absorptiometry, DXA
timeFrame: up to 6 weeks
measure: Body composition_body fat
timeFrame: up to 6 weeks
measure: Body composition_muscle mass
timeFrame: up to 6 weeks
measure: Grip strength
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Safety assessment - AST
timeFrame: up to 6 weeks
measure: Safety assessment - ALT
timeFrame: up to 6 weeks
measure: Safety assessment - T-Cholesterol
timeFrame: up to 6 weeks
measure: Safety assessment - Uric Acid
timeFrame: up to 6 weeks
measure: Safety assessment - BUN
timeFrame: up to 6 weeks
measure: Safety assessment - Creatinine
timeFrame: up to 6 weeks
measure: Safety assessment - Glucose
timeFrame: up to 6 weeks
measure: Safety assessment - Triglycerides
timeFrame: up to 6 weeks
measure: Safety assessment - LDL
timeFrame: up to 6 weeks
measure: Safety assessment - HDL
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Graduate Institute of Sports Science, National Taiwan Sport University
Study officials:
References: