Ketone Supplementation in Individuals With PTSD

Not Applicable

• Conditions: PTSD; Ketosis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Pruvit Ketomax Ketone Salt

• Registration Number: NCT04083352
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-30
• Study First Submitted: 2019-08-05
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-10
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diagnosed with PTSD

Exclusion Criteria

• Pregnant, younger than 18 or older than 65

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6-week placebo supplement	Placebo	Participants took a placebo supplement for 6-weeks. The placebo was calorie, sodium, and flavor-matched to the experimental supplement.
6-week ketone supplementation	Pruvit Ketomax Ketone Salt	Participants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day.

Primary Outcome Measures

Name	Time	Method
Change in Comprehensive Metabolic Panel	Pre- and Post- 6-week supplemental period	Blood health marker
Change in Urinalysis	Pre- and Post- 6-week supplemental period	Health measure
Change in Complete Blood Count	Pre- and Post- 6-week supplemental period	Blood health marker
Change in Cognitive Performance	Pre- and Post- 6-week supplemental period	ANAM test battery
Change in Blood Pressure	Pre- and Post- 6-week supplemental period	Cardiovascular health measure

Secondary Outcome Measures

Name	Time	Method
Change in Emotional Health	Pre- and Post- 6-week supplemental period	Mood Disorder Questionnaire
Change in alcohol use	Pre- and Post- 6-week supplemental period	Alcohol Use Disorders Questionnaire
Change in PTSD	Pre- and Post- 6-week supplemental period	Adverse Childhood Experience Questionnaire
Change in Insomnia	Pre- and Post- 6-week supplemental period	Insomnia Severity Questionnaire
Change in pain	Pre- and Post- 6-week supplemental period	Pain Outcomes Questionnaire

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States