Traumatic Brain InjuryTBISNCT01495871
Amino Acid Supplementation in Recovery From Traumatic Brain Injury
A study testing Amino Acids and Valine in people with Traumatic Brain Injury, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial summary
Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It has been called the "signature wound" of the Iraq war because of its frequency among troops. TBI is associated with many chronic disabilities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Amino Acids and Valine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Jul 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of traumatic brain injury
- Age 18-65 years
- Ability to sign informed consent
- >3 months post-injury, <36 months post-injury
- Ambulatory or require minimal to moderate assistance for safe ambulation
Who cannot join
- Subjects with cardiac abnormalities considered exclusionary by the study physicians
- Subjects with uncontrolled metabolic disease, including liver or renal disease
- Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma
- Any subject currently on a weight-loss diet or a body mass index >34 kg/m2
- Recent anabolic or corticosteroids use (within 3 months)
- Dementia
Show all 9Show fewer
- Inability to tolerate an upright position
- Postural reflexes prohibiting ambulation and inability to follow 2-step commands
- Any other condition or event considered exclusionary by the PIs and covering physician
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Transitional Learning Center
Galveston, Texas, 77550
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It has been called the "signature wound" of the Iraq war because of its frequency among troops. TBI is associated with many chronic disabilities. Physical alterations include reduced exercise tolerance and profound muscle weakness, whereas psychological alterations include diminished sense of well-being, depression, fatigue and anxiety. Muscle and brain tissues rely upon circulating blood amino acids as precursors for metabolic functions. The investigators have shown that even one year after injury, plasma valine, an essential amino acid (EAA), was markedly reduced in patients with TBI compared to healthy controls. The investigators speculate that low plasma valine concentration contributes to chronic fatigue after TBI, since valine and tryptophan compete for the same transporter into the brain, and a low plasma valine concentration will allow more tryptophan to be transported. As a consequence, increased brain tryptophan will increase serotonin production, which may significantly contribute to the development of fatigue. Thus, the investigators will test if restoring valine concentration in persons with TBI may reduce fatigue perception and improve physical and neuropsychological function. Further, the investigators have previously shown that EAA intake has an anabolic effect in healthy young and elderly individuals. However, no data are currently available in persons recovering from TBI. Thus,the investigators will also test if EAA and/or valine can improve muscle mass in patients with TBI.
- Conditions
- Traumatic Brain Injury
- Being tested
- Amino Acids, Placebo of inert compounds, Valine
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino AcidsDietary supplement
15 grams amino acids two times per day for 6 weeks
Placebo of inert compoundsDietary supplement
Placebo two times per day for 6 weeks
ValineDietary supplement
2.5 grams valine supplementation two times a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amino acids | Active comparator | Amino acid supplementation for 6 weeks Receives: Dietary Supplement: Amino Acids |
| Placebo | Placebo comparator | Supplementation of placebo (inert components)for 6 weeks Receives: Dietary Supplement: Placebo of inert compounds |
| Valine | Active comparator | Valine supplementation for 6 weeks Receives: Dietary Supplement: Valine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Essential Amino Acid Concentrations
TBI patients are deficient in a number of essential amino acids (EAA) post injury and we have shown that TBI patient are deficient in valine up to 17 months post injury. We propose to assess plasma amino acid concentrations in TBI patients who are receiving EAA supplementation or valine supplementation compared to placebo patients.
Measured: 6 weeks
Secondary outcomes (1)
Functional impairments
Reduced plasma EAAs may be related to the psychological and metabolic complications associated with TBIs. We aim to assess measures of psychological and physical functionality in TBI patients receiving EAA supplementation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: PI decided not to pursue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Moody Foundation
- Responsible party
- Sponsor
- Investigators
- Melinda Sheffield-Moore, Ph.D., Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495871
- Sponsor's protocol ID
- 10-276
- Acronym
- TBIS
- Status last verified
- Feb 2015
- First submitted
- 16 Dec 2011
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Supplementation in Recovery From Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01495871
- Acronym / sponsor ID
- TBIS / 10-276
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided not to pursue this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- The Moody Foundation
- Study start
- Nov 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Dec 2011 (estimated)
- 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.
Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It has been called the "signature wound" of the Iraq war because of its frequency among troops. TBI is associated with many chronic disabilities. Physical alterations include reduced exercise tolerance and profound muscle weakness, whereas psychological alterations include diminished sense of well-being, depression, fatigue and anxiety. Muscle and brain tissues rely upon circulating blood amino acids as precursors for metabolic functions. The investigators have shown that even one year after injury, plasma valine, an essential amino acid (EAA), was markedly reduced in patients with TBI compared to healthy controls. The investigators speculate that low plasma valine concentration contributes to chronic fatigue after TBI, since valine and tryptophan compete for the same transporter into the brain, and a low plasma valine concentration will allow more tryptophan to be transported. As a consequence, increased brain tryptophan will increase serotonin production, which may significantly contribute to the development of fatigue. Thus, the investigators will test if restoring valine concentration in persons with TBI may reduce fatigue perception and improve physical and neuropsychological function. Further, the investigators have previously shown that EAA intake has an anabolic effect in healthy young and elderly individuals. However, no data are currently available in persons recovering from TBI. Thus,the investigators will also test if EAA and/or valine can improve muscle mass in patients with TBI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amino acids | Active comparator | Dietary Supplement: Amino AcidsAmino acid supplementation for 6 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo of inert compoundsSupplementation of placebo (inert components)for 6 weeks |
| Valine | Active comparator | Dietary Supplement: ValineValine supplementation for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of traumatic brain injury
- Age 18-65 years
- Ability to sign informed consent
- >3 months post-injury, <36 months post-injury
- Ambulatory or require minimal to moderate assistance for safe ambulation
Key exclusion criteria (9 listed)
- Subjects with cardiac abnormalities considered exclusionary by the study physicians
- Subjects with uncontrolled metabolic disease, including liver or renal disease
- Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma
- Any subject currently on a weight-loss diet or a body mass index >34 kg/m2
- Recent anabolic or corticosteroids use (within 3 months)
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 |
|---|---|---|
| Amino Acids15 grams amino acids two times per day for 6 weeks | Dietary supplement | Amino acids |
| Placebo of inert compoundsPlacebo two times per day for 6 weeks | Dietary supplement | Placebo |
| Valine2.5 grams valine supplementation two times a day for 6 weeks | Dietary supplement | Valine |
Primary outcome
Essential Amino Acid Concentrations
Time frame: 6 weeks
TBI patients are deficient in a number of essential amino acids (EAA) post injury and we have shown that TBI patient are deficient in valine up to 17 months post injury. We propose to assess plasma amino acid concentrations in TBI patients who are receiving EAA supplementation or valine supplementation compared to placebo patients.
1 secondary outcome
Functional impairments
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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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.
Melinda Sheffield-Moore, Ph.D. principal investigator
The University of Texas Medical Branch, Galveston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acids and Valine in people with Traumatic Brain Injury, run by The University of Texas Medical Branch, Galveston at 2 sites 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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Essential Amino Acid Concentrations (time frame: 6 weeks). 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 11 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.