Pilot Study of BCAA on Sleep

Portland VA Medical Center

Status: Enrolling

Conditions: Traumatic Brain Injury; Sleep Disorder

Treatments: Dietary Supplement: Branched Chain Amino Acids; Dietary Supplement: Rice Protein; Dietary Supplement: Microcrystalline Cellulose

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03990909

MIRB 4312

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veteran
• English Speaking
• Accessible via phone
• Sleep problems

Exclusion criteria

• Decisional impairment
• Nickel allergy
• Maple syrup urine disease or family history of disease
• Allergy to sucralose
• Currently taking BCAAs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 3 patient groups, including a placebo group

BCAAs

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Branched Chain Amino Acids

Rice Protein

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Rice Protein

Microcrystalline Cellulose

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Microcrystalline Cellulose