Effects of Exogenous Ketones in Healthy Young Adults

Healthy Young Adults Clinical Trial

Official title:

Effects of Exogenous Ketones in Healthy Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452761
• Other study ID #: 10414835
• Status: Completed
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 1, 2018
• Start date: July 14, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: March 2018
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy (no known conditions)

Exclusion Criteria:

• Chronic smoker Pregnant

Related Conditions & MeSH terms

• Healthy Young Adults

Intervention

Dietary Supplement:
• Ketone Salts
Subjects will take 2 servings of ketone salts daily for 6 weeks

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	Funding source: Pruvit Ventures, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood health parameters	Comprehensive Metabolic Panel	6 weeks on the supplement
Primary	Blood health parameter	Complete blood count	6 weeks on the supplement
Primary	Blood health parameter	Lipid Panel	6 weeks on the supplement
Primary	Blood health parameter	Insulin	6 weeks on the supplement
Primary	Blood ketone levels	Blood ketones assessed 30- and 60 minutes after consuming the supplement	Baseline and 6 weeks after chronic consumption
Primary	Cardiovascular	Blood Pressure	6 weeks on the supplement
Primary	Body Composition	Skinfold measure	6 weeks on the supplement
Primary	Body Composition	Weight	6 weeks on the supplement