Effects of Exogenous Ketones in Healthy Young Adults

March 1, 2018 updated by: Angelia Holland, Augusta University
Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose of this study is to determine the effects and safety of supplementing with exogenous ketones for 6-weeks in healthy college-aged males and females. The results of this proposed study will determine whether exogenous ketone supplementation can be useful in promoting better body composition, energy levels, and blood cholesterol, glucose, and insulin levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 22 subjects, male and female, were randomized to either a ketone salt group or a placebo group. Both the participants and investigators were blinded, as the supplements were coded by an external lab. Data was collected at baseline and again in 6-weeks. Participants consumed 2 servings of the assigned supplement daily for 6 weeks. Measures included body composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel, complete blood count, and lipid panel), and a urinalysis. Also, blood ketone levels were assessed before and periodically after consuming the supplemental drink (30 and 60 minutes post drink). These measures were performed at both baseline and 6-weeks later.

Study Type

Interventional

Enrollment (Actual)

22

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy (no known conditions)

Exclusion Criteria:

  • Chronic smoker Pregnant

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood health parameters
Time Frame: 6 weeks on the supplement
Comprehensive Metabolic Panel
6 weeks on the supplement
Blood health parameter
Time Frame: 6 weeks on the supplement
Complete blood count
6 weeks on the supplement
Blood health parameter
Time Frame: 6 weeks on the supplement
Lipid Panel
6 weeks on the supplement
Blood health parameter
Time Frame: 6 weeks on the supplement
Insulin
6 weeks on the supplement
Blood ketone levels
Time Frame: Baseline and 6 weeks after chronic consumption
Blood ketones assessed 30- and 60 minutes after consuming the supplement
Baseline and 6 weeks after chronic consumption
Cardiovascular
Time Frame: 6 weeks on the supplement
Blood Pressure
6 weeks on the supplement
Body Composition
Time Frame: 6 weeks on the supplement
Skinfold measure
6 weeks on the supplement
Body Composition
Time Frame: 6 weeks on the supplement
Weight
6 weeks on the supplement

Collaborators and Investigators

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

Sponsor

Augusta University

Collaborators

Funding source: Pruvit Ventures, Inc

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)

July 14, 2017

Primary Completion (Actual)

October 27, 2017

Study Completion (Actual)

October 27, 2017

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10414835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All data will be deidentified

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.

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