Effects of Exogenous Ketones in Healthy Young Adults

Not Applicable

Completed

• Conditions: Healthy Young Adults

• Registration Number: NCT03452761
• Lead Sponsor: Augusta University

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.

Study Timeline

• Study Start: 2017-07-14
• Primary Completion: 2017-10-27
• Study Completion: 2017-10-27
• Study First Submitted: 2018-02-26
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-01
• Last Update Submitted: 2018-03-01
• Study First Posted: 2018-03-02
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Healthy (no known conditions)

Exclusion Criteria

• Chronic smoker Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood ketone levels	Baseline and 6 weeks after chronic consumption	Blood ketones assessed 30- and 60 minutes after consuming the supplement
Blood health parameters	6 weeks on the supplement	Comprehensive Metabolic Panel
Blood health parameter	6 weeks on the supplement	Insulin
Cardiovascular	6 weeks on the supplement	Blood Pressure
Body Composition	6 weeks on the supplement	Weight

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States