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OpenTrials
Completed

NCT Number: NCT03452761

Effects of Exogenous Ketones in Healthy Young Adults

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.

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Key information

Conditions

Healthy Young Adults Acid-Base Imbalance Acidosis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University

Augusta, Georgia, 30909, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy (no known conditions)

Exclusion criteria

  • Chronic smoker Pregnant

Treatment and study plan

Ketone Salts

Dietary Supplement

Subjects will take 2 servings of ketone salts daily for 6 weeks

Other names: Exogenous Ketone Salts, Pruvit Keto OS

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • Funding source: Pruvit Ventures, Inc

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2018
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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