Pilot Study of BCAA on Sleep
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03990909|
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorder Traumatic Brain Injury||Dietary Supplement: Branched Chain Amino Acids Dietary Supplement: Rice Protein Dietary Supplement: Microcrystalline Cellulose||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids on Sleep|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||August 1, 2024|
|Estimated Study Completion Date :||August 1, 2025|
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 to 21 days (42 total drinks).
Dietary Supplement: Branched Chain Amino Acids
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 Name: BCAAs
Placebo Comparator: Rice Protein
Rice protein control group: 60 grams of rice protein consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21 days (42 total drinks).
Dietary Supplement: Rice Protein
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).
Placebo Comparator: Microcrystalline Cellulose
Placebo control group: 60 grams of microcrystalline cellulose, consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21 days (42 total drinks).
Dietary Supplement: Microcrystalline Cellulose
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).
- Recruitment and retention rates [ Time Frame: 5 weeks ]Number enrolled per month, proportion who complete the protocol
- Rates of adherence and treatment fidelity [ Time Frame: 5 weeks ]Proportion of subjects consuming full doses
- Assessment process and patient acceptability [ Time Frame: 5 weeks ]Proportion of questionnaires properly completed, actiwatches properly worn, and patient acceptance of protocol
- Change in Insomnia Severity Index (ISI) [ Time Frame: Baseline; after 3 weeks of intervention ]Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990909
|Contact: Miranda M Lim, MD, PhD||503-220-8262 ext Ext. firstname.lastname@example.org|
|United States, Oregon|
|VA Portland Health Care System||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Miranda M Lim, MD, PhD 503-220-8262 ext 57404 email@example.com|
|Principal Investigator:||Miranda M Lim, MD, PhD||Portland VA Medical Center|