Effects of Exogenous Ketones in Healthy Young Adults

NCT ID: NCT03452761

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-14
• Study Completion Date: 2017-10-27

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.

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.

Conditions

Healthy Young Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Interventions

Ketone Salts

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Exogenous Ketone Salts, Pruvit Keto OS

Eligibility Criteria

Inclusion Criteria

• Healthy (no known conditions)

Exclusion Criteria

• Chronic smoker Pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Funding source: Pruvit Ventures, Inc

UNKNOWN

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Angelia Holland

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Augusta University

Augusta, Georgia, United States

Countries

United States

Other Identifiers

10414835

Identifier Type: -

Identifier Source: org_study_id