Effects of Exogenous Ketones in Healthy Young Adults

NCT03452761 | Completed

• 1 other identifier: 10414835
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Young Adults

Keywords

exogenous ketone salts; ketosis; safety; comprehensive metabolic panel; complete blood count; lipid panel; insulin

Outcome Measures

Primary Outcomes (8)

• Blood health parameters

  Comprehensive Metabolic Panel

  6 weeks on the supplement

• Blood health parameter

  Complete blood count

  6 weeks on the supplement

• Blood health parameter

  Lipid Panel

  6 weeks on the supplement

• Blood health parameter

  Insulin

  6 weeks on the supplement

• Blood ketone levels

  Blood ketones assessed 30- and 60 minutes after consuming the supplement

  Baseline and 6 weeks after chronic consumption

• Cardiovascular

  Blood Pressure

  6 weeks on the supplement

• Body Composition

  Skinfold measure

  6 weeks on the supplement

• Body Composition

  Weight

  6 weeks on the supplement

Interventions

Ketone Salts DIETARY_SUPPLEMENT

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

Also known as: Exogenous Ketone Salts, Pruvit Keto OS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy (no known conditions)

You may not qualify if:

• Chronic smoker Pregnant

Sponsors & Collaborators

• Augusta University: lead
• Funding source: Pruvit Ventures, Inc: collaborator

Study Sites (1)

Augusta University

Augusta, Georgia, 30909, United States

Location

MeSH Terms

Conditions

Ketosis; Insulin Resistance

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Supplemental packets were not labeled except with the code A or B - placed by the supplement laboratory. PI notified of groups after completion.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, double-blinded, 2-groups (condition and placebo)

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: July 14, 2017
• Primary Completion: October 27, 2017
• Study Completion: October 27, 2017
• Last Updated: March 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)