VA Portland Health Care System
Portland, Oregon, 97239, United States
Location status: Recruiting
NCT Number: NCT03990909
Individuals will be recruited from the VA Portland Health Care System and the community affiliated with Oregon Health & Science University. Traumatic brain injury status will be assessed as a contributing factor. Subjects will be randomized to one of 3 groups (BCAA or one of 2 placebo conditions) and instructed to consume study product twice daily for 21 days. Self-report questionnaires, wrist actigraphy, pressure pain testing, and cognitive function will be assessed pre and post the experimental period.
Interested in participating?
Request Info18 year–89 year
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
Location status: Recruiting
The goal of this proposal is to explore the feasibility of, and potential for, dietary supplementation with branched chain amino acids (BCAAs) to effect sleep quality and cognitive function in Veterans. The BCAAs (Leucine, Isoleucine, and Valine) cannot be synthesized endogenously (i.e., they must be obtained through the diet) and are the precursors to >50% of de novo glutamate and GABA synthesis in the brain, which are the primary excitatory and inhibitory neurotransmitters, respectively. Preclinical evidence strongly suggests that dietary BCAA supplementation restores normal sleep-wake patterns and cognitive function following TBI through a restoration in the global cortical excitation:inhibition ratio. BCAA supplementation has been studied extensively in healthy humans and in a variety of disease states, including following TBI, but not yet in Veterans in the chronic phase of recovery from TBI. BCAAs are a commercially available dietary supplement and very well tolerated with minimal side-effects.
Subjects will be randomized in a double-blind fashion through the VA Research Pharmacy to one of three groups: 1) BCAA; 60 g/day in two 30 g doses, 2) rice protein; 60 g/day in two 30 g doses, and 3) placebo; 60 g microcrystalline cellulose in two 30 g doses. BCAA and placebo will be prepared by the VA Research Pharmacy and dispensed in a blinded fashion to Veterans after demonstrating informed consent. Following a ~4-week period of baseline, Veterans will be instructed to consume study product after waking and ~6 hours later, on an empty stomach for a period of up to 21-days. Self-report questionnaires assessing sleep quality, cognitive function, trauma-related symptom severity, and other measures of mental and physical well-being will be administered before and after the experimental period. Wrist actigraphy will be continuously collected over the baseline and the experimental period. Cognitive function will be assessed before and after the experimental period using an established battery of neuropsychological tests (i.e., selected tests from WAIS, D-KEFS, HVLT, COWAT, among others. Pressure pain testing will be conducted before and after the experimental period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60 grams of BCAA (2:1:1 ratio of Leucine:Isoleucine:Valine) consumed in two doses (30 grams each) mixed into 20 oz of water for up to21days (42 total drinks).
Other names: BCAAs
60 grams of rice protein consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21days (42 total drinks).
60 grams of microcrystalline cellulose, consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21days (42 total drinks).
Time frame: 5 weeks
Number enrolled per month, proportion who complete the protocol
Time frame: 5 weeks
Proportion of subjects consuming full doses
Time frame: 5 weeks
Proportion of questionnaires properly completed, actiwatches properly worn, and patient acceptance of protocol
Time frame: Baseline; after 3 weeks of intervention
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Contact information is provided by the study sponsor or research team.
Portland VA Medical Center
Fed
A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids on Sleep
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06399952
Autism Spectrum Disorder, Autism or Autistic Traits
Columbia, Missouri, United States
View Trial DetailsNCT03255408
Apnea, Blood Pressure
Calgary, Alberta, Canada
View Trial DetailsNCT05382754
Apnea, Dyssomnias
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT07485790
Mental Disorders, Nervous System Diseases
Amasya, Turkey (Türkiye)
View Trial Details