Ketone Supplementation in Individuals With PTSD

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04083352
• Other study ID #: 907405
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed with PTSD

Exclusion Criteria:

• Pregnant, younger than 18 or older than 65

Related Conditions & MeSH terms

• Ketosis
• PTSD

Intervention

Dietary Supplement:
• Pruvit Ketomax Ketone Salt
6-week supplementation with ketone salts
• Placebo
Placebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement.

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Comprehensive Metabolic Panel	Blood health marker	Pre- and Post- 6-week supplemental period
Primary	Change in Complete Blood Count	Blood health marker	Pre- and Post- 6-week supplemental period
Primary	Change in Cognitive Performance	ANAM test battery	Pre- and Post- 6-week supplemental period
Primary	Change in Blood Pressure	Cardiovascular health measure	Pre- and Post- 6-week supplemental period
Primary	Change in Urinalysis	Health measure	Pre- and Post- 6-week supplemental period
Secondary	Change in Insomnia	Insomnia Severity Questionnaire	Pre- and Post- 6-week supplemental period
Secondary	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
Secondary	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
Secondary	Change in Emotional Health	Mood Disorder Questionnaire	Pre- and Post- 6-week supplemental period
Secondary	Change in alcohol use	Alcohol Use Disorders Questionnaire	Pre- and Post- 6-week supplemental period
Secondary	Change in PTSD	PTSD Checklist for DSM-5	Pre- and Post- 6-week supplemental period
Secondary	Change in PTSD	Patient Health Questionnaire-9	Pre- and Post- 6-week supplemental period
Secondary	Change in pain	Pain Outcomes Questionnaire	Pre- and Post- 6-week supplemental period
Secondary	Change in PTSD	Adverse Childhood Experience Questionnaire	Pre- and Post- 6-week supplemental period