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| Name | Class |
|---|---|
| Funding source: Pruvit Ventures, Inc | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Salts | Dietary Supplement | Subjects will take 2 servings of ketone salts daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood health parameters | Comprehensive Metabolic Panel | 6 weeks on the supplement |
| Blood health parameter | Complete blood count | 6 weeks on the supplement |
| Blood health parameter | Lipid Panel | 6 weeks on the supplement |
| Blood health parameter | Insulin | 6 weeks on the supplement |
| Blood ketone levels | Blood ketones assessed 30- and 60 minutes after consuming the supplement | Baseline and 6 weeks after chronic consumption |
| Cardiovascular | Blood Pressure | 6 weeks on the supplement |
| Body Composition | Skinfold measure | 6 weeks on the supplement |
| Body Composition | Weight | 6 weeks on the supplement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University | Augusta | Georgia | 30909 | United States |
All data will be deidentified
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized, double-blinded, 2-groups (condition and placebo)
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Supplemental packets were not labeled except with the code A or B - placed by the supplement laboratory. PI notified of groups after completion.
| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |