Amino Acid Supplementation in Recovery From Traumatic Brain Injury

NCT ID: NCT01495871

Last Updated: 2015-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Amino acids

Amino acid supplementation for 6 weeks

Group Type ACTIVE_COMPARATOR

Amino Acids

Intervention Type DIETARY_SUPPLEMENT

15 grams amino acids two times per day for 6 weeks

Placebo

Supplementation of placebo (inert components)for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo of inert compounds

Intervention Type DIETARY_SUPPLEMENT

Placebo two times per day for 6 weeks

Valine

Valine supplementation for 6 weeks

Group Type ACTIVE_COMPARATOR

Valine

Intervention Type DIETARY_SUPPLEMENT

2.5 grams valine supplementation two times a day for 6 weeks

Interventions

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Amino Acids

15 grams amino acids two times per day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo of inert compounds

Placebo two times per day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Valine

2.5 grams valine supplementation two times a day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Moody Foundation

OTHER

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melinda Sheffield-Moore, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch, Galveston

Locations

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Transitional Learning Center

Galveston, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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10-276

Identifier Type: -

Identifier Source: org_study_id

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