Amino Acid Supplementation in Recovery From Traumatic Brain Injury
Nøgleord
Abstrakt
Datoer
Sidst bekræftet: | 01/31/2015 |
Først indsendt: | 12/15/2011 |
Anslået tilmelding indsendt: | 12/18/2011 |
Først indsendt: | 12/19/2011 |
Sidste opdatering indsendt: | 02/09/2015 |
Sidste opdatering indsendt: | 02/10/2015 |
Faktisk startdato for undersøgelsen: | 10/31/2011 |
Anslået primær afslutningsdato: | 06/30/2014 |
Anslået afslutningsdato for undersøgelsen: | 06/30/2014 |
Tilstand eller sygdom
Intervention / behandling
Dietary Supplement: Amino acids
Dietary Supplement: Placebo
Dietary Supplement: Valine
Fase
Armgrupper
Arm | Intervention / behandling |
---|---|
Active Comparator: Amino acids Amino acid supplementation for 6 weeks | Dietary Supplement: Amino acids 15 grams amino acids two times per day for 6 weeks |
Placebo Comparator: Placebo Supplementation of placebo (inert components)for 6 weeks | Dietary Supplement: Placebo Placebo two times per day for 6 weeks |
Active Comparator: Valine Valine supplementation for 6 weeks | Dietary Supplement: Valine 2.5 grams valine supplementation two times a day for 6 weeks |
Kriterier for støtteberettigelse
Alder berettiget til undersøgelse | 18 Years Til 18 Years |
Køn, der er berettiget til undersøgelse | All |
Accepterer sunde frivillige | Ja |
Kriterier | 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 |
Resultat
Primære resultatforanstaltninger
1. Essential Amino Acid Concentrations [6 weeks]
Sekundære resultatforanstaltninger
1. Functional impairments [6 weeks]