Amino AcidNCT05412667
Investigation of TWK10 Administration on the Effects of Amino Acid Absorption
A study testing TWK10 in people with Amino Acid and Exercise, run by Chi-Chang Huang at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acid, Exercise, Probiotic
- What is being tested?
- TWK10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have exercise habits (exercise at least 3 times a week for at least 30 minutes each time),
- Healthy body
Who cannot join
- Smoking
- Alcohol consumption
- Cardiovascular disease
- Neuromuscular disease
- Metabolic disease
- Asthma, pregnant or breastfeeding
- BMI>27
- Allergic to peanuts .
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Graduate Institute of Sports Science, National Taiwan Sport University
Taoyuan, 33301
About this study
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.
- Conditions
- Amino Acid, Exercise, Probiotic, Body Composition
- Being tested
- TWK10, Placebo
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWK10Dietary supplement
- 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.
PlaceboOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Pea protein without TWK10 (20g/day) Receives: Other: Placebo |
| TWK10 | Experimental | Pea protein (20g/day) with TWK10 (10 billion CFU/day) Receives: Dietary Supplement: TWK10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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 (%)
Measured: 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
Measured: 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
Measured: From Baseline to 4 Weeks Assessed
Bench press test
Bench press with Smith machine and add weight to find individual 1RM
Measured: From Baseline to 4 Weeks Assessed
Secondary outcomes (4)
Checklist Individual Strength (CIS) questionnaire
Assessing subjects' living conditions using the CIS scale. 1 is the least match, 5 is the most match
Measured: 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
Measured: 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
Measured: 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
Measured: From Baseline to 4 Weeks Assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Nov 2021
- Primary completion31 Dec 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi-Chang Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Synbio Tech Inc.
- Responsible party
- Sponsor-investigator, Chi-Chang Huang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412667
- Sponsor's protocol ID
- 21-035-B1
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of TWK10 Administration on the Effects of Amino Acid Absorption
- ClinicalTrials.gov ID
- NCT05412667
- Acronym / sponsor ID
- 21-035-B1
- Conditions
- Amino Acid, Exercise, Probiotic, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chi-Chang HuangUniversity, hospital or other
- Collaborators
- Synbio Tech Inc.
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPea protein without TWK10 (20g/day) |
| TWK10 | Experimental | Dietary Supplement: TWK10Pea protein (20g/day) with TWK10 (10 billion CFU/day) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have exercise habits (exercise at least 3 times a week for at least 30 minutes each time),
- Healthy body
Key exclusion criteria (8 listed)
- Smoking
- Alcohol consumption
- Cardiovascular disease
- Neuromuscular disease
- Metabolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TWK101. 4 days without training: drink 2 hours before bedtime. 2. 3 days of training: drink within 30 minutes after training (uniformly brewed in the laboratory). 3. To analyze the amino acid concentration in blood, drink it immediately before blood collection. | Dietary supplement | TWK10 |
| Placebo1. 4 days without training: drink 2 hours before bedtime. 2. 3 days of training: drink within 30 minutes after training (uniformly brewed in the laboratory). 3. To analyze the amino acid concentration in blood, drink it immediately before blood collection. | Other | Placebo |
Primary outcome
Amino acid
Time frame: From Baseline to 4 Weeks Assessed, including time point: baseline, 30 minutes, 60 minutes, 120 minutes, and 180 minutes post ingestion)
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.
Muscle composition
Time frame: From Baseline to 4 Weeks Assessed
Use muscular ultrasound (BenQ T3300) to scan
Isometric Mid-Thigh Pull (IMTP)
Time frame: From Baseline to 4 Weeks Assessed
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.
Isometric Mid-Thigh Pull (IMTP)
Time frame: From Baseline to 4 Weeks Assessed
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)
Time frame: From Baseline to 4 Weeks Assessed
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)
Wingate Anaerobic Test (WAnT)
Time frame: From Baseline to 4 Weeks Assessed
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)
Wingate Anaerobic Test (WAnT)
Time frame: From Baseline to 4 Weeks Assessed
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 (%)
dual-energy X-ray absorptiometry, DXA
Time frame: From Baseline to 4 Weeks Assessed
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
dual-energy X-ray absorptiometry, DXA
Time frame: From Baseline to 4 Weeks Assessed
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
Bench press test
Time frame: From Baseline to 4 Weeks Assessed
Bench press with Smith machine and add weight to find individual 1RM
4 secondary outcomes
Checklist Individual Strength (CIS) questionnaire
Time frame: From Baseline to 4 Weeks Assessed
Visual Analog Fatigue Scale (VAFS)
Time frame: From Baseline to 4 Weeks Assessed
Rating of Perceived Exertion (RPE) scale
Time frame: From Baseline to 4 Weeks Assessed
3-day dietary recording four weeks
Time frame: From Baseline to 4 Weeks Assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TWK10 in people with Amino Acid and Exercise, run by Chi-Chang Huang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amino acid (time frame: From Baseline to 4 Weeks Assessed, including time point: baseline, 30 minutes, 60 minutes, 120 minutes, and 180 minutes post ingestion)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.