Absorption of Amino Acids and PeptidesNCT05024123
Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects
A study testing AstraGin in people with Absorption of Amino Acids and Peptides, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
AstraGin increases the absorption of amino acids and peptides in Caco-2 cells and in normal and TNBS-induced rats. Given the potential beneficial applications of AstraGin for health, the effects on L-arginine uptake and nitric oxide production are investigated. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Absorption of Amino Acids and Peptides
- What is being tested?
- AstraGin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Apr 2021to 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults and age 20 years and above, subdivided into three groups, Early-life (younger than 45 years, midlife (45--65 years), and later-life (older than 65 years), respectively.
- Subject has provided written and dated informed consent to participate in the study.
- The subject is willing and able to comply with the study.
Who cannot join
- The subject is participating in another clinical trial thirty days prior to enroll-ment.
- Subject has diabetes, obesity, hypertension, cardiovascular disease, liver or kid-ney disease, current infections, and smoking were exclusion criteria.
- Subject has any medical condition or uses any medication, nutritional product, amino acids supplement or program which might interfere with the conduct of the study or place the subject at risk.
- Subjects lost to follow-up, non-compliance, concomitant medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects: A Randomized, Double-blind, Crossover Trial
AstraGin increases the absorption of amino acids and peptides in Caco-2 cells and in normal and TNBS-induced rats. Given the potential beneficial applications of AstraGin for health, the effects on L-arginine uptake and nitric oxide production are investigated. The study is the L-arginine pharmacokinetic study: A randomized, double-blind, crossover trial. This study performed in healthy human subjects. The knowledge gained from this study will provide valuable information for the development of novel and effective natural food supplements.
- Conditions
- Absorption of Amino Acids and Peptides
- Being tested
- Placebo, AstraGin
- Keywords
- AstraGin, arginine, pharmacokinetic, nitric oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Before each study day, the participants were subjected to a reduced nitrate content diet (avoid foods such as dark chocolate, beets, garlic, nuts and seeds, bacon, ham, and hot dogs,, day-1) for 24h. All subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water in the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 5 g of L-arginine with 250 mL water.
Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min for analysis of the plasma concentration of amino acids, total nitrite, nitrate, and asymmetric dimethylarginine (ADMA) content.
All subjects collected their urine during 0 ~ 180 min to measure 1) nitrate and 2) cGMP content.
AstraGinDietary supplement
Before each study day, the participants were subjected to a reduced nitrate content diet (avoid foods such as dark chocolate, beets, garlic, nuts and seeds, bacon, ham, and hot dogs,, day-1) for 24h. All subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water in the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 5 g of L-arginine with 250 mL water.
Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min for analysis of the plasma concentration of amino acids, total nitrite, nitrate, and asymmetric dimethylarginine (ADMA) content.
All subjects collected their urine during 0 ~ 180 min to measure 1) nitrate and 2) cGMP content.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Experimental | Experimental | Not described Receives: Dietary Supplement: AstraGin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [Cmax]
Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)
Measured: 3 hours
Maximum Time [Tmax]
Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start6 Apr 2021
- Primary completionOct 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absorption of Amino Acids and PeptidesStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You-Cheng Shen, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024123
- Sponsor's protocol ID
- CS2-20203
- Status last verified
- Aug 2021
- First submitted
- 20 May 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects: A Randomized, Double-blind, Crossover Trial
- ClinicalTrials.gov ID
- NCT05024123
- Acronym / sponsor ID
- CS2-20203
- Conditions
- Absorption of Amino Acids and Peptides
- Keywords
- AstraGin, arginine, pharmacokinetic, nitric oxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 27 Aug 2021 (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.
AstraGin increases the absorption of amino acids and peptides in Caco-2 cells and in normal and TNBS-induced rats. Given the potential beneficial applications of AstraGin for health, the effects on L-arginine uptake and nitric oxide production are investigated. The study is the L-arginine pharmacokinetic study: A randomized, double-blind, crossover trial. This study performed in healthy human subjects. The knowledge gained from this study will provide valuable information for the development of novel and effective natural food supplements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Experimental | Experimental | Dietary Supplement: AstraGin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults and age 20 years and above, subdivided into three groups, Early-life (younger than 45 years, midlife (45--65 years), and later-life (older than 65 years), respectively.
- Subject has provided written and dated informed consent to participate in the study.
- The subject is willing and able to comply with the study.
Key exclusion criteria (4 listed)
- The subject is participating in another clinical trial thirty days prior to enroll-ment.
- Subject has diabetes, obesity, hypertension, cardiovascular disease, liver or kid-ney disease, current infections, and smoking were exclusion criteria.
- Subject has any medical condition or uses any medication, nutritional product, amino acids supplement or program which might interfere with the conduct of the study or place the subject at risk.
- Subjects lost to follow-up, non-compliance, concomitant medication.
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 |
|---|---|---|
| PlaceboBefore each study day, the participants were subjected to a reduced nitrate content diet (avoid foods such as dark chocolate, beets, garlic, nuts and seeds, bacon, ham, and hot dogs,, day-1) for 24h. All subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water in the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 5 g of L-arginine with 250 mL water. Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min for analysis of the plasma concentration of amino acids, total nitrite, nitrate, and asymmetric dimethylarginine (ADMA) content. All subjects collected their urine during 0 ~ 180 min to measure 1) nitrate and 2) cGMP content. | Dietary supplement | Placebo |
| AstraGinBefore each study day, the participants were subjected to a reduced nitrate content diet (avoid foods such as dark chocolate, beets, garlic, nuts and seeds, bacon, ham, and hot dogs,, day-1) for 24h. All subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water in the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 5 g of L-arginine with 250 mL water. Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min for analysis of the plasma concentration of amino acids, total nitrite, nitrate, and asymmetric dimethylarginine (ADMA) content. All subjects collected their urine during 0 ~ 180 min to measure 1) nitrate and 2) cGMP content. | Dietary supplement | Experimental |
Primary outcome
Maximum Plasma Concentration [Cmax]
Time frame: 3 hours
Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)
Maximum Time [Tmax]
Time frame: 3 hours
Pharmacokinetic ( 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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 AstraGin in people with Absorption of Amino Acids and Peptides, run by Chung Shan Medical University 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Aug 2021. 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?
Results are not available in the source record.
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?
Maximum Plasma Concentration [Cmax] (time frame: 3 hours). The study lists 2 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 27 Aug 2021.