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Ketone Supplementation in Individuals With PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083352
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Augusta University

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.

Condition or disease Intervention/treatment Phase
PTSD Ketosis Dietary Supplement: Pruvit Ketomax Ketone Salt Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Exogenous Ketone Supplementation or a Ketogenic Diet in Individuals With PTSD
Actual Study Start Date : August 30, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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.




Primary Outcome Measures :
  1. Change in Comprehensive Metabolic Panel [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Blood health marker

  2. Change in Complete Blood Count [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Blood health marker

  3. Change in Cognitive Performance [ Time Frame: Pre- and Post- 6-week supplemental period ]
    ANAM test battery

  4. Change in Blood Pressure [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Cardiovascular health measure

  5. Change in Urinalysis [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Health measure


Secondary Outcome Measures :
  1. Change in Insomnia [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Insomnia Severity Questionnaire

  2. Change in Emotional Health [ Time Frame: 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).

  3. Change in Emotional Health [ Time Frame: Pre- and Post- 6-week supplemental period ]
    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)

  4. Change in Emotional Health [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Mood Disorder Questionnaire

  5. Change in alcohol use [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Alcohol Use Disorders Questionnaire

  6. Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    PTSD Checklist for DSM-5

  7. Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Patient Health Questionnaire-9

  8. Change in pain [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Pain Outcomes Questionnaire

  9. Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Adverse Childhood Experience Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosed with PTSD

Exclusion Criteria:

  • Pregnant, younger than 18 or older than 65

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083352


Locations
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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30909
Contact: Angelia M Holland    706-731-7912    angholland@augusta.edu   
Sponsors and Collaborators
Augusta University
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Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT04083352    
Other Study ID Numbers: 907405
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases