Trial Outcomes & Findings for Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2 (NCT NCT04417218)
NCT ID: NCT04417218
Last Updated: 2023-12-21
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Change from pre-diet to post-diet (1 week)
Results posted on
2023-12-21
Participant Flow
N=20 enrolled individuals withdrew or were lost to follow up prior to starting the intervention.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (1 Week))
STARTED
|
25
|
22
|
|
First Intervention (1 Week))
COMPLETED
|
24
|
22
|
|
First Intervention (1 Week))
NOT COMPLETED
|
1
|
0
|
|
Washout (2 Weeks)
STARTED
|
24
|
22
|
|
Washout (2 Weeks)
COMPLETED
|
24
|
22
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
24
|
22
|
|
Second Intervention (1 Week)
COMPLETED
|
24
|
22
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (1 Week))
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
Baseline characteristics by cohort
| Measure |
Dietary Intervention
n=47 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from pre-diet to post-diet (1 week)Population: 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.
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).
Outcome measures
| Measure |
Normal Lysine Diet
n=43 Participants
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.
|
High Lysine Diet
n=42 Participants
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.
|
|---|---|---|
|
Change in Plasma 2-AAA Concentration From Baseline
|
-9.35 ng/ml
Standard Deviation 30.3
|
7.02 ng/ml
Standard Deviation 23.7
|
Adverse Events
Normal Lysine Diet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High Lysine Diet
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Lysine Diet
n=47 participants at risk
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.
|
High Lysine Diet
n=46 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
2.1%
1/47 • Number of events 1 • Adverse events data were collected over the 4 week study period.
|
8.7%
4/46 • Number of events 4 • Adverse events data were collected over the 4 week study period.
|
|
Psychiatric disorders
Changes in mood
|
0.00%
0/47 • Adverse events data were collected over the 4 week study period.
|
2.2%
1/46 • Number of events 1 • Adverse events data were collected over the 4 week study period.
|
|
Nervous system disorders
Headache
|
0.00%
0/47 • Adverse events data were collected over the 4 week study period.
|
2.2%
1/46 • Number of events 1 • Adverse events data were collected over the 4 week study period.
|
|
Psychiatric disorders
Change in mood
|
0.00%
0/47 • Adverse events data were collected over the 4 week study period.
|
2.2%
1/46 • Number of events 1 • Adverse events data were collected over the 4 week study period.
|
|
Blood and lymphatic system disorders
Bruising
|
2.1%
1/47 • Number of events 1 • Adverse events data were collected over the 4 week study period.
|
0.00%
0/46 • Adverse events data were collected over the 4 week study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place