The Effects of Exogenous Ketone Supplementation or a Ketogenic Diet in Individuals With PTSD
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Augusta University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in Comprehensive Metabolic Panel
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosed with PTSD
Exclusion Criteria
- •Pregnant, younger than 18 or older than 65
Arms & Interventions
6-week ketone supplementation
Participants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day.
Intervention: Pruvit Ketomax Ketone Salt (Dietary Supplement)
6-week placebo supplement
Participants took a placebo supplement for 6-weeks. The placebo was calorie, sodium, and flavor-matched to the experimental supplement.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Comprehensive Metabolic Panel
Time Frame: Pre- and Post- 6-week supplemental period
Blood health marker
Change in Urinalysis
Time Frame: Pre- and Post- 6-week supplemental period
Health measure
Change in Complete Blood Count
Time Frame: Pre- and Post- 6-week supplemental period
Blood health marker
Change in Cognitive Performance
Time Frame: Pre- and Post- 6-week supplemental period
ANAM test battery
Change in Blood Pressure
Time Frame: Pre- and Post- 6-week supplemental period
Cardiovascular health measure
Secondary Outcomes
- Change in Emotional Health(Pre- and Post- 6-week supplemental period)
- Change in PTSD(Pre- and Post- 6-week supplemental period)
- Change in alcohol use(Pre- and Post- 6-week supplemental period)
- Change in Insomnia(Pre- and Post- 6-week supplemental period)
- Change in pain(Pre- and Post- 6-week supplemental period)