PTSDNCT04083352
Ketone Supplementation in Individuals With PTSD
A study testing Pruvit Ketomax Ketone Salt in people with PTSD and Ketosis, run by Augusta University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Pruvit Ketomax Ketone Salt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with PTSD
Who cannot join
- Pregnant, younger than 18 or older than 65
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30909
Angelia M Holland, 706-731-7912, angholland@augusta.edu
About this study
Official title: 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.
- Being tested
- Pruvit Ketomax Ketone Salt, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pruvit Ketomax Ketone SaltDietary supplement
6-week supplementation with ketone salts
PlaceboDietary supplement
Placebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement.
| Study group | Role | What they receive |
|---|---|---|
| 6-week ketone supplementation | Experimental | Participants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day. Receives: Dietary Supplement: Pruvit Ketomax Ketone Salt |
| 6-week placebo supplement | Placebo comparator | Participants took a placebo supplement for 6-weeks. The placebo was calorie, sodium, and flavor-matched to the experimental supplement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Comprehensive Metabolic Panel
Blood health marker
Measured: Pre- and Post- 6-week supplemental period
Change in Complete Blood Count
Blood health marker
Measured: Pre- and Post- 6-week supplemental period
Change in Cognitive Performance
ANAM test battery
Measured: Pre- and Post- 6-week supplemental period
Change in Blood Pressure
Cardiovascular health measure
Measured: Pre- and Post- 6-week supplemental period
Change in Urinalysis
Health measure
Measured: Pre- and Post- 6-week supplemental period
Secondary outcomes (9)
Change in Insomnia
Insomnia Severity Questionnaire
Measured: 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).
Measured: 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)
Measured: Pre- and Post- 6-week supplemental period
Change in Emotional Health
Mood Disorder Questionnaire
Measured: Pre- and Post- 6-week supplemental period
Change in alcohol use
Alcohol Use Disorders Questionnaire
Measured: Pre- and Post- 6-week supplemental period
Change in PTSD
PTSD Checklist for DSM-5
Measured: Pre- and Post- 6-week supplemental period
Change in PTSD
Patient Health Questionnaire-9
Measured: Pre- and Post- 6-week supplemental period
Change in pain
Pain Outcomes Questionnaire
Measured: Pre- and Post- 6-week supplemental period
Change in PTSD
Adverse Childhood Experience Questionnaire
Measured: Pre- and Post- 6-week supplemental period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start30 Aug 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083352
- Sponsor's protocol ID
- 907405
- Status last verified
- Sep 2019
- First submitted
- 5 Aug 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exogenous Ketone Supplementation or a Ketogenic Diet in Individuals With PTSD
- ClinicalTrials.gov ID
- NCT04083352
- Acronym / sponsor ID
- 907405
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-week ketone supplementation | Experimental | Dietary Supplement: Pruvit Ketomax Ketone SaltParticipants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day. |
| 6-week placebo supplement | Placebo comparator | Dietary Supplement: PlaceboParticipants took a placebo supplement for 6-weeks. The placebo was calorie, sodium, and flavor-matched to the experimental supplement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with PTSD
Key exclusion criteria (1 listed)
- Pregnant, younger than 18 or older than 65
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pruvit Ketomax Ketone Salt6-week supplementation with ketone salts | Dietary supplement | 6-week ketone supplementation |
| PlaceboPlacebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement. | Dietary supplement | 6-week placebo supplement |
Primary outcome
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
9 secondary outcomes
Change in Insomnia
Time frame: Pre- and Post- 6-week supplemental period
Change in Emotional Health
Time frame: Pre- and Post- 6-week supplemental period
Change in Emotional Health
Time frame: Pre- and Post- 6-week supplemental period
Change in Emotional Health
Time frame: Pre- and Post- 6-week supplemental period
Change in alcohol use
Time frame: Pre- and Post- 6-week supplemental period
Change in PTSD
Time frame: Pre- and Post- 6-week supplemental period
Change in PTSD
Time frame: Pre- and Post- 6-week supplemental period
Change in pain
Time frame: Pre- and Post- 6-week supplemental period
Change in PTSD
Time frame: Pre- and Post- 6-week supplemental period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for PTSD
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pruvit Ketomax Ketone Salt in people with PTSD and Ketosis, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Comprehensive Metabolic Panel (time frame: Pre- and Post- 6-week supplemental period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.