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Effects of Exogenous Ketones in Healthy Young Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452761
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Funding source: Pruvit Ventures, Inc
Information provided by (Responsible Party):
Angelia Holland, Augusta University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Young Adults Dietary Supplement: Ketone Salts Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blinded, 2-groups (condition and placebo)
Masking: Double (Participant, Investigator)
Masking Description: Supplemental packets were not labeled except with the code A or B - placed by the supplement laboratory. PI notified of groups after completion.
Primary Purpose: Screening
Official Title: Effects of Exogenous Ketones in Healthy Young Adults
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : October 27, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arms and Interventions
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Intervention Details:
  • Dietary Supplement: Ketone Salts
    Subjects will take 2 servings of ketone salts daily for 6 weeks
    Other Name: Exogenous Ketone Salts, Pruvit Keto OS

Outcome Measures
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Primary Outcome Measures :
  1. Blood health parameters [ Time Frame: 6 weeks on the supplement ]
    Comprehensive Metabolic Panel

  2. Blood health parameter [ Time Frame: 6 weeks on the supplement ]
    Complete blood count

  3. Blood health parameter [ Time Frame: 6 weeks on the supplement ]
    Lipid Panel

  4. Blood health parameter [ Time Frame: 6 weeks on the supplement ]
    Insulin

  5. Blood ketone levels [ Time Frame: Baseline and 6 weeks after chronic consumption ]
    Blood ketones assessed 30- and 60 minutes after consuming the supplement

  6. Cardiovascular [ Time Frame: 6 weeks on the supplement ]
    Blood Pressure

  7. Body Composition [ Time Frame: 6 weeks on the supplement ]
    Skinfold measure

  8. Body Composition [ Time Frame: 6 weeks on the supplement ]
    Weight


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy (no known conditions)

Exclusion Criteria:

  • Chronic smoker Pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452761


Locations
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United States, Georgia
Augusta University
Augusta, Georgia, United States, 30909
Sponsors and Collaborators
Augusta University
Funding source: Pruvit Ventures, Inc
More Information
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Responsible Party: Angelia Holland, Assistant Professor, Augusta University
ClinicalTrials.gov Identifier: NCT03452761    
Other Study ID Numbers: 10414835
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be deidentified

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angelia Holland, Augusta University:
exogenous ketone salts
ketosis
safety
comprehensive metabolic panel
 complete blood count
lipid panel
insulin