Ketosis, PTSD
Conditions
Brief summary
The purpose of this study is to determine if a 6-week period of ketone salt supplementation affects physiological, emotional, cognitive, and/or behavioral health markers in individuals with PTSD.
Interventions
DIETARY_SUPPLEMENTPruvit Ketomax Ketone Salt
6-week supplementation with ketone salts
DIETARY_SUPPLEMENTPlacebo
Placebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement.
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with PTSD
Exclusion criteria
* Pregnant, younger than 18 or older than 65
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinalysis | Pre- and Post- 6-week supplemental period | Health measure |
| Change in Comprehensive Metabolic Panel | Pre- and Post- 6-week supplemental period | Blood health marker |
| Change in Complete Blood Count | Pre- and Post- 6-week supplemental period | Blood health marker |
| Change in Cognitive Performance | Pre- and Post- 6-week supplemental period | ANAM test battery |
| Change in Blood Pressure | Pre- and Post- 6-week supplemental period | Cardiovascular health measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia | Pre- and Post- 6-week supplemental period | Insomnia Severity Questionnaire |
| Change in Emotional Health | Pre- and Post- 6-week supplemental period | Title: 12-Item Grit Scale; Construct: measures trait-level perserverance and passion for long-term goals; the scale for each question includes the following answers to check: Very much like me, mostly like me, somewhat like me, not much like me, not like me at all; Scoring: for questions 1, 4, 6, 9, 10, and 12 the following answers receive the associated number as a score: Very much like me (5), Mostly like me (4), Somewhat like me (3), Not much like me (2), Not like me at all (1). And questions 2, 3, 5, 7, 8, and 11 receive the following points for the checked answers: Very much like me (1 points), Mostly like me (2 points), Somewhat like me (3 points), Not much like me (4 points), Not like me at all (5 points). Add up all the points and divide by 12. The maximum score on this scale is 5 (extremely gritty) and the lowest score is 1 (not at all gritty). |
| Change in alcohol use | Pre- and Post- 6-week supplemental period | Alcohol Use Disorders Questionnaire |
| Change in PTSD | Pre- and Post- 6-week supplemental period | PTSD Checklist for DSM-5 |
| Change in pain | Pre- and Post- 6-week supplemental period | Pain Outcomes Questionnaire |
Countries
United States
Outcome results
None listed