Amino Acid Supplementation in Recovery From Traumatic Brain Injury

NCT01495871 | Withdrawn

• 1 other identifier: 10-276
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Functional impairments

  6 weeks

Study Arms (3)

Amino acids

ACTIVE COMPARATOR

Amino acid supplementation for 6 weeks

Dietary Supplement: Amino Acids

Placebo

PLACEBO COMPARATOR

Supplementation of placebo (inert components)for 6 weeks

Dietary Supplement: Placebo of inert compounds

Valine

ACTIVE COMPARATOR

Valine supplementation for 6 weeks

Dietary Supplement: Valine

Interventions

Amino Acids DIETARY_SUPPLEMENT

15 grams amino acids two times per day for 6 weeks

Amino acids

Placebo of inert compounds DIETARY_SUPPLEMENT

Placebo two times per day for 6 weeks

Placebo

Valine DIETARY_SUPPLEMENT

2.5 grams valine supplementation two times a day for 6 weeks

Valine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to tolerate an upright position
• Postural reflexes prohibiting ambulation and inability to follow 2-step commands

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• The Moody Foundation: collaborator

Study Sites (2)

Transitional Learning Center

Galveston, Texas, 77550, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Amino Acids; Valine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Amino Acids, Branched-Chain; Amino Acids, Essential

Study Officials

• Melinda Sheffield-Moore, Ph.D.

  The University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 20, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 11, 2015

Record last verified: 2015-02

Locations

US (2)