Ketone Supplementation in Individuals With PTSD

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

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 Overview

• Status: Unknown
• Conditions: PTSD; Ketosis
• Intervention / Treatment: Dietary supplement: Pruvit Ketomax Ketone Salt; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Recruiting
      • Augusta University
      • Contact: Angelia M Holland; Phone Number: 706-731-7912; Email: angholland@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with PTSD

Exclusion Criteria:

• Pregnant, younger than 18 or older than 65

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID Numbers: 907405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No