Ketone Supplementation in Individuals With PTSD

NCT ID: NCT04083352

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-30

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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PTSD Ketosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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6-week ketone supplementation

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

Group Type EXPERIMENTAL

Pruvit Ketomax Ketone Salt

Intervention Type DIETARY_SUPPLEMENT

6-week supplementation with ketone salts

6-week placebo supplement

Participants took a placebo supplement for 6-weeks. The placebo was calorie, sodium, and flavor-matched to the experimental supplement.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Pruvit Ketomax Ketone Salt

6-week supplementation with ketone salts

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with PTSD

Exclusion Criteria

* Pregnant, younger than 18 or older than 65
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Augusta University

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Angelia M Holland

Role: primary

706-731-7912

Other Identifiers

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907405

Identifier Type: -

Identifier Source: org_study_id

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