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Trial record 2 of 2 for:    pruvit

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

Tracking Information
First Submitted Date  ICMJE August 5, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE August 30, 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Change in Comprehensive Metabolic Panel [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Blood health marker
  • 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
  • Change in Urinalysis [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Health measure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2019)
  • Change in Insomnia [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Insomnia Severity Questionnaire
  • 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).
  • 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)
  • Change in Emotional Health [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Mood Disorder Questionnaire
  • Change in alcohol use [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Alcohol Use Disorders Questionnaire
  • Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    PTSD Checklist for DSM-5
  • Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Patient Health Questionnaire-9
  • Change in pain [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Pain Outcomes Questionnaire
  • Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Adverse Childhood Experience Questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Change in Insomnia [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Insomnia Severity Questionnaire
  • Change in Emotional Health [ Time Frame: Pre- and Post- 6-week supplemental period ]
    12-Item Grit Scale
  • Change in Emotional Health [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Visual Analog Scales
  • Change in Emotional Health [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Mood Disorder Questionnaire
  • Change in alcohol use [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Alcohol Use Disorders Questionnaire
  • Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    PTSD Checklist for DSM-5
  • Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Patient Health Questionnaire-9
  • Change in pain [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Pain Outcomes Questionnaire
  • Change in PTSD [ Time Frame: Pre- and Post- 6-week supplemental period ]
    Adverse Childhood Experience Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketone Supplementation in Individuals With PTSD
Official Title  ICMJE The Effects of Exogenous Ketone Supplementation or a Ketogenic Diet in Individuals With PTSD
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • PTSD
  • Ketosis
Intervention  ICMJE
  • Dietary Supplement: Pruvit Ketomax Ketone Salt
    6-week supplementation with ketone salts
  • Dietary Supplement: Placebo
    Placebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement.
Study Arms  ICMJE
  • Experimental: 6-week ketone supplementation
    Participants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day.
    Intervention: Dietary Supplement: Pruvit Ketomax Ketone Salt
  • 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.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with PTSD

Exclusion Criteria:

  • Pregnant, younger than 18 or older than 65
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04083352
Other Study ID Numbers  ICMJE 907405
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Augusta University
Study Sponsor  ICMJE Augusta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Augusta University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP