Amino Acid Supplementation in Recovery From Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— TBIS  

Official title:

Amino Acid Supplementation in Recovery From Traumatic Brain Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01495871
• Other study ID #: 10-276
• Status: Withdrawn
• Phase: N/A
• First received: December 16, 2011
• Last updated: February 10, 2015
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Presence of traumatic brain injury

2. Age 18-65 years

3. Ability to sign informed consent

4. >3 months post-injury, <36 months post-injury

5. Ambulatory or require minimal to moderate assistance for safe ambulation

Exclusion Criteria:

1. Subjects with cardiac abnormalities considered exclusionary by the study physicians

2. Subjects with uncontrolled metabolic disease, including liver or renal disease

3. Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma

4. Any subject currently on a weight-loss diet or a body mass index >34 kg/m2

5. Recent anabolic or corticosteroids use (within 3 months)

6. Dementia

7. Inability to tolerate an upright position

8. Postural reflexes prohibiting ambulation and inability to follow 2-step commands

9. Any other condition or event considered exclusionary by the PIs and covering physician

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Dietary Supplement:
• Amino Acids
15 grams amino acids two times per day for 6 weeks
• Placebo of inert compounds
Placebo two times per day for 6 weeks
• Valine
2.5 grams valine supplementation two times a day for 6 weeks

Locations

Country	Name	City	State
United States	Transitional Learning Center	Galveston	Texas
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	The Moody Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks	No
Secondary	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.	6 weeks	No