Investigation of TWK10 Administration on the Effects of Amino Acid Absorption

The most common problem among sports people is that no matter how much protein food or products they eat, their sports performance cannot be improved, resulting in failure to achieve breakthroughs in sports performance. The cause of the trouble is digestion and absorption problems. The key is intestinal problems. If gastrointestinal function is maintained in a healthy state, then exercise performance must be maintained at a considerable level. Therefore, how to choose the source of protein in the diet is one of the most concerned issues of the sports crowd. Although past studies have confirmed that the essential amino acids in animal protein can be absorbed and utilized better than plant protein, plant protein can be broken down into easily digestible peptides and amino acids by pepsin. Promote the metabolite pool in the large intestine and the amino acid balance of the host in the small intestine. Recent studies have pointed out that the proteases and peptidases in lactic acid bacteria can provide free amino acids for the best growth of bacteria, and can increase the distribution of amino acids in the blood, the speed of muscle synthesis and the content of branched chain amino acids. However, the mechanism of action of Lactobacillus plantarum on protein digestion and amino acid absorption in the host is still unclear. Therefore, the purpose of this study is to explore the effect of supplementing sports lactic acid bacteria TWK10 in human experiments to effectively improve the amino acid bioabsorption rate of plant protein supplements. 40 subjects were randomly divided into 2 groups, each with 20 people (male and female): (1) pea protein without TWK10 (placebo), (2) TWK10 group (TWK10). The two groups of subjects were supplemented with test samples for 28 consecutive days and performed paired sports training 3 times a week. Before and after the intervention, the samples were subjected to exercise testing, blood and fecal sample collection, body composition analysis, and muscle mass analysis.

Study Overview

• Status: Completed
• Conditions: Exercise; Body Composition; Amino Acid; Probiotic
• Intervention / Treatment: Other: Placebo; Dietary supplement: TWK10

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33301
    • Graduate Institute of Sports Science, National Taiwan Sport University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have exercise habits (exercise at least 3 times a week for at least 30 minutes each time),
• Healthy body

Exclusion Criteria:

• Smoking
• Alcohol consumption
• Cardiovascular disease
• Neuromuscular disease
• Metabolic disease
• Asthma, pregnant or breastfeeding
• BMI>27
• Allergic to peanuts .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Pea protein without TWK10 (20g/day)	Other: Placebo; 4 days without training: drink 2 hours before bedtime.; 3 days of training: drink within 30 minutes after training (uniformly brewed in the laboratory).; To analyze the amino acid concentration in blood, drink it immediately before blood collection.
Experimental: TWK10; Pea protein (20g/day) with TWK10 (10 billion CFU/day)	Dietary supplement: TWK10; 4 days without training: drink 2 hours before bedtime.; 3 days of training: drink within 30 minutes after training (uniformly brewed in the laboratory).; To analyze the amino acid concentration in blood, drink it immediately before blood collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amino acid	Liquid chromatography tandem mass spectrometry (LC-MS/MS) was used for analysis, wherein the liquid chromatography system was Acquity UPLC, and the column used was Waters C18 column (2.1 × 150 mm, 1.8 μm), and the temperature of the column was set at 45 °C, the mobile phases used were water and 100% acetonitrile, both of which contained 0.1% formic acid, the flow rate was 0.6 mL/min, and the injection volume of the test solution was 2 μL.	From Baseline to 4 Weeks Assessed, including time point: baseline, 30 minutes, 60 minutes, 120 minutes, and 180 minutes post ingestion)
Muscle composition	Use muscular ultrasound (BenQ T3300) to scan	From Baseline to 4 Weeks Assessed
Isometric Mid-Thigh Pull (IMTP)	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 force (PF) were recorded.	From Baseline to 4 Weeks Assessed
Isometric Mid-Thigh Pull (IMTP)	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.	From Baseline to 4 Weeks Assessed
Wingate Anaerobic Test (WAnT)	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 recorded results were the relative mean power (W/kg)	From Baseline to 4 Weeks Assessed
Wingate Anaerobic Test (WAnT)	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 recorded results were the relative peak power (W/kg)	From Baseline to 4 Weeks Assessed
Wingate Anaerobic Test (WAnT)	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 recorded results were the fatigue index (%)	From Baseline to 4 Weeks Assessed
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	From Baseline to 4 Weeks Assessed
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 fat mass	From Baseline to 4 Weeks Assessed
Bench press test	Bench press with Smith machine and add weight to find individual 1RM	From Baseline to 4 Weeks Assessed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Checklist Individual Strength (CIS) questionnaire	Assessing subjects' living conditions using the CIS scale. 1 is the least match, 5 is the most match	From Baseline to 4 Weeks Assessed
Visual Analog Fatigue Scale (VAFS)	Using the VAS scale to measure the subjective feelings of the subjects after exercise, 1 is the least tired, 5 is the most tired	From Baseline to 4 Weeks Assessed
Rating of Perceived Exertion (RPE) scale	Use the RPE scale to record how hard the subjects are after the test, 6 points are the least hard, 20 points are the hardest	From Baseline to 4 Weeks Assessed
3-day dietary recording four weeks	After 4 weeks of intervention, the 3-day diet was recorded and the calorie intake was calculated by the dietitian	From Baseline to 4 Weeks Assessed

Collaborators and Investigators

• Sponsor: Chi-Chang Huang
• Collaborators: SYNBIO TECH INC.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21-035-B1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No