Effects of Exogenous Ketones in Healthy Young Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Augusta University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Body Composition
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Double (Participant, Investigator)
Masking Description
Supplemental packets were not labeled except with the code A or B - placed by the supplement laboratory. PI notified of groups after completion.
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy (no known conditions)
Exclusion Criteria
- •Chronic smoker Pregnant
Outcomes
Primary Outcomes
Body Composition
Time Frame: 6 weeks on the supplement
Skinfold measure
Blood health parameter
Time Frame: 6 weeks on the supplement
Complete blood count
Blood health parameters
Time Frame: 6 weeks on the supplement
Comprehensive Metabolic Panel
Blood ketone levels
Time Frame: Baseline and 6 weeks after chronic consumption
Blood ketones assessed 30- and 60 minutes after consuming the supplement
Cardiovascular
Time Frame: 6 weeks on the supplement
Blood Pressure
Secondary Outcomes
No secondary outcomes reported
Investigators
Angelia Holland
Assistant Professor
Augusta University