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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK117144 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lysine | Dietary Supplement | Lysine is an essential amino acid which is acquired from dietary sources. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Change from pre-diet to post-diet (1 week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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N=20 enrolled individuals withdrew or were lost to follow up prior to starting the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Lysine Diet First Then High Lysine Diet | Participants completed two one-week dietary interventions, in a randomized order, separated by a 2-week washout. For the Normal Lysine diet, participants were asked to adhere to a specific diet for 1 week. Individuals were instructed to consume specific foods, to adhere to a controlled lysine diet. This comprised 3 meals and 1-2 snacks per day during the study period. For the Washout, individuals were asked to resume their habitual diet for 2 weeks. For the High Lysine diet, participants were asked to adhere to a specific diet for 1 week. Individuals were instructed to consume the same specific foods, as the Normal Lysine diet. This comprised 3 meals and 1-2 snacks per day during the study period. Participants were also instructed to take Lysine supplements with their meals (5g/day). Lysine: Lysine is an essential amino acid which is acquired from dietary sources. Controlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. |
| FG001 | High Lysine Diet First Then Normal Lysine Diet | Participants completed two one-week dietary interventions, in a randomized order, separated by a 2-week washout. For the High Lysine diet, participants were asked to adhere to a specific diet for 1 week. Individuals were instructed to consume specific foods. This comprised 3 meals and 1-2 snacks per day during the study period. Participants were also instructed to take Lysine supplements with their meals (5g/day). For the Washout, individuals were asked to resume their habitual diet for 2 weeks. For the Normal Lysine diet, participants were asked to adhere to a specific diet for 1 week. Individuals were instructed to consume specific foods (the same as during the High Lysine diet), to adhere to a controlled lysine diet. This comprised 3 meals and 1-2 snacks per day during the study period. Lysine: Lysine is an essential amino acid which is acquired from dietary sources. Controlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week)) |
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| Washout (2 Weeks) |
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| Second Intervention (1 Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dietary Intervention | 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. Controlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. 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). Lysine: Lysine is an essential amino acid which is acquired from dietary sources. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Individuals were included for analysis only if they had provided a blood sample for measurement of 2-AAA at both the pre- and post-diet timepoints. This excluded 3 individuals from the normal lysine diet intervention, and 4 individuals from the high lysine diet intervention. | Posted | Mean | Standard Deviation | ng/ml | Change from pre-diet to post-diet (1 week) |
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Adverse events data were collected over the 4 week study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Lysine Diet | 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. Controlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment | Reports of bloating, gas, or GI discomfort |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jane Ferguson | Vanderbilt University Medical Center | 6158759896 | jane.f.ferguson@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2020 | Nov 28, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2022 | Feb 16, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008239 | Lysine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Controlled Diet | Dietary Supplement | Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | High Lysine Diet | 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). Lysine: Lysine is an essential amino acid which is acquired from dietary sources. Controlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. |
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| 0 |
| 47 |
| 0 |
| 47 |
| 2 |
| 47 |
| EG001 | High Lysine Diet | 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). Lysine: Lysine is an essential amino acid which is acquired from dietary sources. Controlled Diet: Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet. | 0 | 46 | 0 | 46 | 7 | 46 |
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| Changes in mood | Psychiatric disorders | Non-systematic Assessment | reported improvement in mood |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Change in mood | Psychiatric disorders | Non-systematic Assessment | reported nervousness |
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| Bruising | Blood and lymphatic system disorders | Non-systematic Assessment | Reported pain and bruising following blood draw. |
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| D000601 | Amino Acids, Essential |