Ketone Supplementation in Individuals With PTSD

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Exogenous Ketone Supplementation or a Ketogenic Diet in Individuals With PTSD

Conditions
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PTSD, Ketosis

Intervention / Treatment
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* Dietary Supplement: Pruvit Ketomax Ketone Salt
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with PTSD Exclusion Criteria: Pregnant, younger than 18 or older than 65

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6-week ketone supplementation<br>Participants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day. | Dietary Supplement: Pruvit Ketomax Ketone Salt<br>* 6-week supplementation with ketone salts<br>|
| Placebo Comparator: 6-week placebo supplement<br>Participants took a placebo supplement for 6-weeks. The placebo was calorie, sodium, and flavor-matched to the experimental supplement. | Dietary Supplement: Placebo<br>* Placebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Comprehensive Metabolic Panel | Blood health marker | Pre- and Post- 6-week supplemental period | 
| Change in Complete Blood Count | Blood health marker | Pre- and Post- 6-week supplemental period | 
| Change in Cognitive Performance | ANAM test battery | Pre- and Post- 6-week supplemental period | 
| Change in Blood Pressure | Cardiovascular health measure | Pre- and Post- 6-week supplemental period | 
| Change in Urinalysis | Health measure | Pre- and Post- 6-week supplemental period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia | Insomnia Severity Questionnaire | Pre- and Post- 6-week supplemental period | 
| Change in Emotional Health | 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). | Pre- and Post- 6-week supplemental period | 
| Change in Emotional Health | Title: Visual Analog Scales; Construct: measures the intensity or frequency of various symptoms; the scale is numerical with numbers from 0 to 10 lined horizontally and 0 indicates no symptom at all, 5 indicated neutral, and 10 indicates the highest feeling of the symptom. Symptoms asked included Hunger (0=not hungry at all, 10= very hungry), Satiety (0=don't feel full at all, 10=very full) , Mood (0= feel very down, 10= feel wonderful), Energy (0= very tired, 10=very energized), Focus (0= very distracted, 10=very focused), Alertness (0=non-coherent, 10= very aware of my surroundings) | Pre- and Post- 6-week supplemental period | 
| Change in Emotional Health | Mood Disorder Questionnaire | Pre- and Post- 6-week supplemental period | 
| Change in alcohol use | Alcohol Use Disorders Questionnaire | Pre- and Post- 6-week supplemental period | 
| Change in PTSD | PTSD Checklist for DSM-5 | Pre- and Post- 6-week supplemental period | 
| Change in PTSD | Patient Health Questionnaire-9 | Pre- and Post- 6-week supplemental period | 
| Change in pain | Pain Outcomes Questionnaire | Pre- and Post- 6-week supplemental period | 
| Change in PTSD | Adverse Childhood Experience Questionnaire | Pre- and Post- 6-week supplemental period |