Trial Outcomes & Findings for Rapid Antidepressant Effects of Leucine (NCT NCT03079297)

Last Updated: 2023-01-26

Results Overview

The Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR), self-report is a 16-item measure of depression severity that includes the 9 criterion symptoms for MDD. Items are scored on a 4-point Likert scale, ranging from 0 to 3 (total score range, 0-27). Totals scores of ≤ 5 indicate no depression; 6-10 indicates mild depression; 11-15 indicates moderate depression; 16-20 indicates severe depression; and ≥ 21 indicates very severe depression. For purposes of this report, severe and very severe categories were combined as "severe to very severe" depression (≥ 16). The QIDS-A self-report has demonstrated acceptable psychometric properties.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2023-01-26

Participant Flow

16 participants were consented, of which 5 were determined as eligible after screening. Of those 5, 1 reported exclusionary criteria at the baseline visit and 4 were randomized.

Participant milestones

Participant milestones
Measure	L-leucine, Then Placebo Participants with 4 gm L-leucine by mouth twice daily for two weeks, then washout for two weeks, then 4 gm maltodextrin by mouth twice daily for two weeks.	Placebo, Then L-leucine Participants start with 4 gm maltodextrin by mouth twice daily for two weeks, then washout for two weeks, then 4 gm L-leucine by mouth twice daily for two weeks.
First Intervention (14 Days) STARTED	2	2
First Intervention (14 Days) COMPLETED	2	2
First Intervention (14 Days) NOT COMPLETED	0	0
Washout (14 Days) STARTED	2	2
Washout (14 Days) COMPLETED	2	2
Washout (14 Days) NOT COMPLETED	0	0
Second Intervention (14 Days) STARTED	2	2
Second Intervention (14 Days) COMPLETED	2	2
Second Intervention (14 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rapid Antidepressant Effects of Leucine

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to 14 days

Outcome measures

Outcome measures
Measure	L-leucine n=4 Participants 4 gm L-leucine by mouth twice daily for two weeks	Maltodextrin n=4 Participants 4 gm maltodextrin by mouth twice daily for two weeks
Change in QIDS-SR From Baseline at 14 Days	-6 score on a scale Standard Deviation 3.16	-8 score on a scale Standard Deviation 3.27

SECONDARY outcome

Timeframe: Baseline to 14 days

Response criteria defined based on QIDS-SR score at baseline and 14 days after treatment initiation. The Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR), self-report is a 16-item measure of depression severity that includes the 9 criterion symptoms for MDD. Items are scored on a 4-point Likert scale, ranging from 0 to 3 (total score range, 0-27). Totals scores of ≤ 5 indicate no depression; 6-10 indicates mild depression; 11-15 indicates moderate depression; 16-20 indicates severe depression; and ≥ 21 indicates very severe depression. For purposes of this report, severe and very severe categories were combined as "severe to very severe" depression (≥ 16). The QIDS-A self-report has demonstrated acceptable psychometric properties.

Outcome measures

Outcome measures
Measure	L-leucine n=4 Participants 4 gm L-leucine by mouth twice daily for two weeks	Maltodextrin n=4 Participants 4 gm maltodextrin by mouth twice daily for two weeks
Percentage of MDD Patients With 50% or Greater Reduction in Depression Severity After 14 Days of LEU and PBO Treatments.	0 percentage of patients	50 percentage of patients

SECONDARY outcome

Timeframe: 14 days

Remission operationalized as QIDS-SR \<=5. The Quick Inventory of Depressive Symptomatology, self-report (QIDS-SR), self-report is a 16-item measure of depression severity that includes the 9 criterion symptoms for MDD. Items are scored on a 4-point Likert scale, ranging from 0 to 3 (total score range, 0-27). Totals scores of ≤ 5 indicate no depression; 6-10 indicates mild depression; 11-15 indicates moderate depression; 16-20 indicates severe depression; and ≥ 21 indicates very severe depression. For purposes of this report, severe and very severe categories were combined as "severe to very severe" depression (≥ 16). The QIDS-A self-report has demonstrated acceptable psychometric properties.

Outcome measures

Outcome measures
Measure	L-leucine n=4 Participants 4 gm L-leucine by mouth twice daily for two weeks	Maltodextrin n=4 Participants 4 gm maltodextrin by mouth twice daily for two weeks
Percentage of MDD Patients With QIDS-SR Score Less Than or Equal to 5 at 14 Days of LEU and PBO Treatments.	0 percentage of patients	25 percentage of patients

SECONDARY outcome

Timeframe: Baseline to 3 days, 7 days, and 14 days

Adverse effect burden will be measured with Frequency Intensity and Burden of Side-effect rating scale (FIBSER). The Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale was designed by Dr. Stephen Wisniewski for use in the U.S. STAR\*D effectiveness study. It is a 3-item scale to assess side effects from antidepressant treatment. To use the FIBSER in measurement-based care, clinicians should consider item 3 (Burden). If the score is 0 to 2 (None to Mild interference with activities), no change in medication is needed. If the score is 3-4 (Moderate to Marked interference with activites), the side effects need to be addressed (i.e., change in dose, side effect antidote, etc). If the score is 5-6 (Severe interference with activities or Unable to Function), the dose needs to be decreased or the medication needs to be switched.

Outcome measures

Outcome measures
Measure	L-leucine n=4 Participants 4 gm L-leucine by mouth twice daily for two weeks	Maltodextrin n=4 Participants 4 gm maltodextrin by mouth twice daily for two weeks
Rates of Adverse Effects After 3 Days, 7 Days and 14 Days of LEU and PBO Treatments. Adverse effect burden function 14 days Change	0 units on a scale Standard Error .06	-.25 units on a scale Standard Error .06
Rates of Adverse Effects After 3 Days, 7 Days and 14 Days of LEU and PBO Treatments. Adverse effect burden 3 days Change	0 units on a scale Standard Error .07	0 units on a scale Standard Error .06
Rates of Adverse Effects After 3 Days, 7 Days and 14 Days of LEU and PBO Treatments. Adverse effect burden function 7 days Change	0 units on a scale Standard Error .07	0 units on a scale Standard Error .06

SECONDARY outcome

Timeframe: Baseline to 3 days, 7 days, and 14 days

Fatigue will be measured with Multidimensional fatigue inventory The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It contains five scales: general fatigue (items 1, 5, 12, 16), mental fatigue (items 7, 11, 13, 19), physical fatigue (items 2, 8, 14, 20), reduced motivation (items 4, 9, 15, 18) and reduced activity (items 3, 6, 10, 17). Items are scored on a 5-point scale on which the participant expressed the degree to which the statement applied to him or her (from agreement "yes, that is true" to disagreement "no, that is not true") in the previous days. Item scores are summed to create a sum score for each scale, ranging between 4 (best condition) and 20 (worst condition). Higher scores indicate more fatigue.

Outcome measures

Outcome measures
Measure	L-leucine n=4 Participants 4 gm L-leucine by mouth twice daily for two weeks	Maltodextrin n=4 Participants 4 gm maltodextrin by mouth twice daily for two weeks
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. General fatigue 3 days Change	-1.59 units on a scale Standard Error 1.93	-0.70 units on a scale Standard Error 1.66
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. General fatigue 7 days Change	-3.59 units on a scale Standard Error 1.93	-3.20 units on a scale Standard Error 1.66
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. General fatigue 14 days Change	-0.74 units on a scale Standard Error 1.67	-3.70 units on a scale Standard Error 1.66
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Mental fatigue 3 days Change	-2.36 units on a scale Standard Error 1.71	-0.71 units on a scale Standard Error 1.62
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Mental fatigue 7 days Change	-1.02 units on a scale Standard Error 1.71	-4.71 units on a scale Standard Error 1.62
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Mental fatigue 14 days Change	-3.46 units on a scale Standard Error 1.62	-3.96 units on a scale Standard Error 1.62
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Physical fatigue 3 days Change	-3.58 units on a scale Standard Error 1.16	-0.55 units on a scale Standard Error 1.08
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Physical fatigue 7 days Change	0.09 units on a scale Standard Error 1.16	-1.80 units on a scale Standard Error 1.08
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Physical fatigue 14 days Change	-2.55 units on a scale Standard Error 1.08	-3.80 units on a scale Standard Error 1.08
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Reduced motivation 3 days Change	-.032 units on a scale Standard Error 1.72	-0.26 units on a scale Standard Error 1.59
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Reduced motivation 7 days Change	-0.71 units on a scale Standard Error 1.94	-1.26 units on a scale Standard Error 1.59
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Reduced motivation 14 days Change	-5.51 units on a scale Standard Error 1.59	-2.76 units on a scale Standard Error 1.59
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Reduced activity 3 days Change	-2.80 units on a scale Standard Error 1.68	-0.47 units on a scale Standard Error 1.51
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Reduced activity 7 days Change	-4.14 units on a scale Standard Error 1.68	-3.97 units on a scale Standard Error 1.51
Change in Fatigue Symptoms From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured With Multidimensional Fatigue Inventory. Reduced activity 14 days Change	-4.47 units on a scale Standard Error 1.51	-8.14 units on a scale Standard Error 1.68

SECONDARY outcome

Timeframe: Baseline to 3 days, 7 days, and 14 days

Psychosocial function will be measured using Work and Social Adjustment Scale The Work and Social Adjustment Scale ("WSAS") is a 5-item measure for impairment in functioning. Items are scored on an 8-point scale on how much participants' problems impaired their ability to carry out the activity (from "Not at all" to "Very severely"). Item scores are summed to create a sum score. The maximum score of the WSAS is 40, lower scores are better. A WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology. Scores below 10 appear to be associated with subclinical populations.

Outcome measures

Outcome measures
Measure	L-leucine n=4 Participants 4 gm L-leucine by mouth twice daily for two weeks	Maltodextrin n=4 Participants 4 gm maltodextrin by mouth twice daily for two weeks
Change in Psychosocial Function From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Work and Social Adjustment Scale. Psychosocial function 3 days Change	1.49 units on a scale Standard Error 5.14	-2.57 units on a scale Standard Error 4.44
Change in Psychosocial Function From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Work and Social Adjustment Scale. Psychosocial function7 days Change	-1.18 units on a scale Standard Error 5.14	-7.57 units on a scale Standard Error 4.44
Change in Psychosocial Function From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Work and Social Adjustment Scale. Psychosocial function 14 days Change	-9.38 units on a scale Standard Error 4.46	-7.32 units on a scale Standard Error 4.44

SECONDARY outcome

Timeframe: Baseline to 3 days, 7 days, and 14 days

Anhedonia will be measured using Snaith-Hamilton Pleasure Scale (SHAPS). The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item scale that measures anhedonia, the inability to experience pleasure. The items cover the domains of: social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14.

Outcome measures

Outcome measures
Measure	L-leucine n=4 Participants 4 gm L-leucine by mouth twice daily for two weeks	Maltodextrin n=4 Participants 4 gm maltodextrin by mouth twice daily for two weeks
Change in Anhedonia From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Snaith-Hamilton Pleasure Scale (SHAPS) Anhedonia 3 days Change	-0.21 units on a scale Standard Error 0.75	-0.46 units on a scale Standard Error 0.65
Change in Anhedonia From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Snaith-Hamilton Pleasure Scale (SHAPS) Anhedonia 7 days Change	0.79 units on a scale Standard Error 0.75	-1.46 units on a scale Standard Error 0.65
Change in Anhedonia From Baseline After 3, 7, and 14 Days of LEU and PBO Treatments Measured Using Snaith-Hamilton Pleasure Scale (SHAPS) Anhedonia 14 days Change	-0.07 units on a scale Standard Error 0.66	-2.21 units on a scale Standard Error 0.65

Adverse Events

L-leucine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Washout Following L-Leucine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Maltodextrin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Washout Following Maltodextrin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	L-leucine n=4 participants at risk AE was reported with a start date within the two week period subject was taking 4 gm L-leucine by mouth twice daily	Washout Following L-Leucine n=4 participants at risk AE was reported with a start date following (within two weeks) the two week period subject was taking 4 gm L-leucine by mouth twice daily	Maltodextrin n=4 participants at risk AE was reported with a start date within the two week period subject was taking 4 gm Maltodextrin by mouth twice daily	Washout Following Maltodextrin n=4 participants at risk AE was reported with a start date following (within two weeks) the two week period subject was taking 4 gm Maltodextrin by mouth twice daily
Investigations Neutrophil count low	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Investigations White blood cell count low	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Skin and subcutaneous tissue disorders Pruritis	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Respiratory, thoracic and mediastinal disorders Viral upper respiratory tract infection	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Investigations AST Increased	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Investigations Red blood cell count low	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Investigations Hemoglobin low	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Investigations Hematocrit low	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Investigations Mean cell hemoglobin concentration increased	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Investigations Platelet count low	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.
Investigations Monocyte count low	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	25.0% 1/4 • Number of events 1 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.	0.00% 0/4 • Adverse Event data was collected for each participant from their Baseline Visit (Day 0) to Day 42, for a total of 43 days. Adverse events were assessed at the end of each visit.

Additional Information

Maria Monastirsky

University of Texas Southwestern

Phone: 214-648-0174

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	A/B (L-leucine/Maltodextrin) n=2 Participants Starts with 4 gm L-leucine by mouth twice daily for two weeks, then washout for two weeks, then 4 gm maltodextrin by mouth twice daily for two weeks.	B/A (Maltodextrin/L-leucine) n=2 Participants Starts with 4 gm maltodextrin by mouth twice daily for two weeks, then washout for two weeks, then 4 gm L-leucine by mouth twice daily for two weeks.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants