NCT06909331

Brief Summary

The purpose of this study is to determine the accuracy of current measuring techniques used to detect physiological ketone levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

January 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 27, 2025

Last Update Submit

March 27, 2025

Conditions

Placebo - ControlExogenous Ketone Salt

Outcome Measures

Primary Outcomes (2)

  • Circulating beta-hydroxybutyrate

    Circulating beta-hydroxybutyrate levels measured by ketone meters and GC/MS

    30 minutes after consuming the drink

  • Circulating acetoacetate levels

    30 minutes after consuming the drink

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

They were provided a placebo drink that was color, calorie and flavor-matched to the experimental drink.

Dietary Supplement: Placebo drink solution

Experimental supplement

EXPERIMENTAL

They were provided an ketone salt drink.

Dietary Supplement: Exogenous ketone salt

Interventions

Exogenous ketone saltDIETARY_SUPPLEMENT

Exogenous ketone salt supplement will be taken once to determine acute circulating levels of beta-hydroxybuyrate and acetoacetate compared to a control supplement.

Experimental supplement
Placebo drink solutionDIETARY_SUPPLEMENT

Participants consumed a placebo drink that was flavor, color and calorie matched to the experimental drink.

Placebo drink

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30909, United States

Location

Study Design

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

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 3, 2025

Study Start

January 15, 2019

Primary Completion

May 30, 2019

Study Completion

December 15, 2019

Last Updated

April 3, 2025

Record last verified: 2025-03

Locations

US(1)