Healthy Young Adults
Conditions
Keywords
exogenous ketone salts, ketosis, safety, comprehensive metabolic panel, complete blood count, lipid panel, insulin
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.
Interventions
DIETARY_SUPPLEMENTKetone Salts
Subjects will take 2 servings of ketone salts daily for 6 weeks
Sponsors
Funding source: Pruvit Ventures, Inc
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, 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.
Intervention model description
Randomized, double-blinded, 2-groups (condition and placebo)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy (no known conditions)
Exclusion criteria
* Chronic smoker Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood health parameters | 6 weeks on the supplement | Comprehensive Metabolic Panel |
| Blood health parameter | 6 weeks on the supplement | Complete blood count |
| Blood ketone levels | Baseline and 6 weeks after chronic consumption | Blood ketones assessed 30- and 60 minutes after consuming the supplement |
| Cardiovascular | 6 weeks on the supplement | Blood Pressure |
| Body Composition | 6 weeks on the supplement | Skinfold measure |
Countries
United States
Outcome results
None listed