Accuracy of Current Techniques in Quantifying Ketone Levels

March 27, 2025 updated by: Augusta University
The purpose of this study is to determine the accuracy of current measuring techniques used to detect physiological ketone levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Augusta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-35 years

Exclusion Criteria:

  • taking medications that affect blood pressure, insulin, or renal function, having meta-bolic syndrome factors such as type 2 diabetes, being pregnant, and/or indicating a pre-existing health condition on the health history questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo drink
They were provided a placebo drink that was color, calorie and flavor-matched to the experimental drink.
Dietary supplement: Placebo drink solution
Participants consumed a placebo drink that was flavor, color and calorie matched to the experimental drink.
Experimental: Experimental supplement
They were provided an ketone salt drink.
Dietary supplement: Exogenous ketone salt
Exogenous ketone salt supplement will be taken once to determine acute circulating levels of beta-hydroxybuyrate and acetoacetate compared to a control supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating beta-hydroxybutyrate
Time Frame: 30 minutes after consuming the drink
Circulating beta-hydroxybutyrate levels measured by ketone meters and GC/MS
30 minutes after consuming the drink
Circulating acetoacetate levels
Time Frame: 30 minutes after consuming the drink
30 minutes after consuming the drink

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IRBnet: 1317538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Placebo - Control

Clinical Trials on Placebo drink solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe