HealthyNCT04417218
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
A study testing Lysine in people with Healthy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lysine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prior participant in 2-AAA screening study.
- Identified as eligible due to high or low plasma 2-AAA, in the absence of hyperglycemia, as defined by study team.
Who cannot join
- Individuals who currently use tobacco products.
- Use of prescription or over-the-counter medications or dietary supplements which could modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to first study visit until completion of study). Hormonal birth control is acceptable.
- Follow a severely restricted diet or have food allergies, which would preclude adherence to study diet.
- Newly diagnosed disease (since screening visit), including cardiovascular, renal, or liver disease, or Diabetes mellitus.
- Individuals who are pregnant or lactating
- Inability to provide written or electronic informed consent
- Inability to fast for 8 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).
Read the detailed description
Diabetes is an important health concern worldwide. It is associated with significantly increased mortality as well as high incidence of co-morbidities. Unfortunately, treatment efficacy and successful disease management is highly variable among treated patients, and this is partly due to the fact that diabetes has multiple underlying causes most of which are still unknown. A newly identified biomarker, α-aminoadipic acid (2-AAA), has the potential to successfully predict the development of diabetes in humans, even before the development of other known risk markers. However, little is known about the function of 2-AAA; it is unclear whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered metabolic processes that then lead to diabetes.
The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy individuals from the general population to identify subjects with high or low 2-AAA. Now in the second phase of the study, 80 subjects with high or low 2-AAA will be invited to participate in a dietary lysine modification study to access the effect of controlled lysine intake on plasma and urine 2AAA. Participants will be asked to complete two one-week dietary interventions. Subjects will be screened and consented via email, online, or phone. Each subject will be required to come to Vanderbilt University Medical Center for four study visits, at which the study team will obtain a blood sample, a urine sample, stool sample, vital signs, waist and hip circumference, and 1-3 surveys will be completed if the subject did not complete them prior to the visit. Each subject that completes the entire study visit will be compensated $250. DNA samples will be obtained to allow for identification of genetic predictors of 2-AAA levels. Some individuals may be asked to return for a future follow-up study.
- Conditions
- Healthy
- Being tested
- Lysine, Controlled Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LysineDietary supplement
Lysine is an essential amino acid which is acquired from dietary sources.
Controlled DietDietary supplement
Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.
| Study group | Role | What they receive |
|---|---|---|
| Normal Lysine Diet | Experimental | Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period. Receives: Dietary Supplement: Controlled Diet |
| High Lysine Diet | Experimental | Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day). Receives: Dietary Supplement: Lysine; Dietary Supplement: Controlled Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma 2-AAA Concentration From Baseline
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as post-diet minus pre-diet for each Intervention (Normal lysine and High lysine).
Measured: Change from pre-diet to post-diet (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start17 Aug 2020
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Ferguson, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417218
- Sponsor's protocol ID
- 200427
- Other IDs
- R01DK117144
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2020
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
- ClinicalTrials.gov ID
- NCT04417218
- Acronym / sponsor ID
- 200427
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).
Detailed description
Diabetes is an important health concern worldwide. It is associated with significantly increased mortality as well as high incidence of co-morbidities. Unfortunately, treatment efficacy and successful disease management is highly variable among treated patients, and this is partly due to the fact that diabetes has multiple underlying causes most of which are still unknown. A newly identified biomarker, α-aminoadipic acid (2-AAA), has the potential to successfully predict the development of diabetes in humans, even before the development of other known risk markers. However, little is known about the function of 2-AAA; it is unclear whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered metabolic processes that then lead to diabetes.
The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy individuals from the general population to identify subjects with high or low 2-AAA. Now in the second phase of the study, 80 subjects with high or low 2-AAA will be invited to participate in a dietary lysine modification study to access the effect of controlled lysine intake on plasma and urine 2AAA. Participants will be asked to complete two one-week dietary interventions. Subjects will be screened and consented via email, online, or phone. Each subject will be required to come to Vanderbilt University Medical Center for four study visits, at which the study team will obtain a blood sample, a urine sample, stool sample, vital signs, waist and hip circumference, and 1-3 surveys will be completed if the subject did not complete them prior to the visit. Each subject that completes the entire study visit will be compensated $250. DNA samples will be obtained to allow for identification of genetic predictors of 2-AAA levels. Some individuals may be asked to return for a future follow-up study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Lysine Diet | Experimental | Dietary Supplement: Controlled DietParticipants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period. |
| High Lysine Diet | Experimental | Dietary Supplement: Lysine, Dietary Supplement: Controlled DietParticipants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Prior participant in 2-AAA screening study.
- Identified as eligible due to high or low plasma 2-AAA, in the absence of hyperglycemia, as defined by study team.
Key exclusion criteria (7 listed)
- Individuals who currently use tobacco products.
- Use of prescription or over-the-counter medications or dietary supplements which could modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to first study visit until completion of study). Hormonal birth control is acceptable.
- Follow a severely restricted diet or have food allergies, which would preclude adherence to study diet.
- Newly diagnosed disease (since screening visit), including cardiovascular, renal, or liver disease, or Diabetes mellitus.
- Individuals who are pregnant or lactating
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 |
|---|---|---|
| LysineLysine is an essential amino acid which is acquired from dietary sources. | Dietary supplement | High Lysine Diet |
| Controlled DietIndividuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. | Dietary supplement | High Lysine Diet, Normal Lysine Diet |
Primary outcome
Change in Plasma 2-AAA Concentration From Baseline
Time frame: Change from pre-diet to post-diet (1 week)
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as post-diet minus pre-diet for each Intervention (Normal lysine and High lysine).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Lysine in people with Healthy, run by Vanderbilt University Medical Center at 1 site in United States.
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 7 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 Dec 2023. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Plasma 2-AAA Concentration From Baseline (time frame: Change from pre-diet to post-diet (1 week)). 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 Dec 2023.