NCT04083352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 18, 2019

Status Verified

September 1, 2019

Enrollment Period

3.3 years

First QC Date

August 5, 2019

Last Update Submit

November 15, 2019

Conditions

PTSDKetosis

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (9)

  • Change in Insomnia

    Pre- and Post- 6-week supplemental period

  • Change in Emotional Health

    Pre- and Post- 6-week supplemental period

  • Change in Emotional Health

    Pre- and Post- 6-week supplemental period

  • Change in Emotional Health

    Pre- and Post- 6-week supplemental period

  • Change in alcohol use

    Pre- and Post- 6-week supplemental period

  • +4 more secondary outcomes

Study Arms (2)

6-week ketone supplementation

EXPERIMENTAL

Participants took a ketomax ketone salt supplementation for 6-weeks. They took 2 servings per day.

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.

Dietary Supplement: Placebo

Interventions

Pruvit Ketomax Ketone SaltDIETARY_SUPPLEMENT

6-week supplementation with ketone salts

6-week ketone supplementation
PlaceboDIETARY_SUPPLEMENT

Placebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement.

6-week placebo supplement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with PTSD

You may not qualify if:

  • Pregnant, younger than 18 or older than 65

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30909, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticKetosis

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

September 10, 2019

Study Start

August 30, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 18, 2019

Record last verified: 2019-09

Locations

US(1)