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Assess the acceptability and tolerability of two different commercially available ketone supplements and determine their effects on capillary blood concentrations of the ketone beta-hydroxybutyrate and glucose in young adults.
Past findings suggest that raising ketone concentrations through the use of a ketogenic diet (high-fat, moderate-protein, low-carbohydrate) is effective for preventing weight gain and decreasing appetite. However, strict adherence to this diet is difficult, and ending the diet can result in the regaining of body weight. Our group has investigated the effects of various ketone supplements in both rodents and humans. Past results of our group and that of our colleagues suggest that ketone supplements have the ability to increase ketone concentrations in the blood, decrease appetite, lower body weight, and maintain lean body mass. Exogenous ketones may serve as an alternative to the ketogenic diet by increasing concentrations of ketones without the need for adherence to a strict diet. However, little is known about ketone supplements as it relates to their tolerability and efficacy. For example, the taste of these supplements is unacceptable to some individuals and it is unclear if ketone supplements provide an adequate approach to raise and maintain circulating ketone concentrations as observed with the ketogenic diet. This information will be valuable before launching larger-scale human trials.
Ketone supplements (KE1 and KE4) will be obtained from KetoneAid (Falls Church, VA). Participants will be asked to drink (5g and 10g) of each supplement separated by at least 3 days. Capillary blood samples will be measured using a handheld device to measure circulating beta-hydroxybutyrate (BHB) and glucose concentrations while a questionnaire will be used to assess the acceptability and tolerability of the ketone supplements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control placebo | Placebo Comparator |
| |
| KE1 5g | Experimental |
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| KE1 10g | Experimental |
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| KE4 5g | Experimental |
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| KE4 10g | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KE1 5g | Dietary Supplement | 5g of KE1 (KetoneAid, Falls Church, VA), diluted to 4 ounces |
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| Measure | Description | Time Frame |
|---|---|---|
| Supplement tolerability and acceptability | The ketone supplements being used have been described as having strong, disagreeable flavors. Therefore, the first outcome measure will be understanding how the flavors and gastrointestinal effects of both supplements may impact subjects. This outcome measure will be assessed by measuring the symptoms experienced, the time at which each symptom occurred, and the duration of each symptom using a scaled symptom questionnaire titled "Symptom Questionnaire." The questionnaire rates symptoms on an ordinal scale from absent, mild, moderate, to severe, with absent being the minimum value and better outcome, and severe being the maximum value and worst outcome. The questionnaire will assess the time that each symptom occurred, on a scale from immediately, one hour, and two hours after supplement consumption. The questionnaire will assess the duration of each symptom, on a scale of less than thirty minutes, one hour, and two hours after each symptom occurred. | 2 hours |
| Capillary beta-hydroxybutyrate concentrations | Exogenous ketone supplements are now widely available at the commercial level, so it is important to understand the concentration-dependent effects of these supplements on circulating ketone concentrations, measured by concentrations of beta-hydroxybutyrate following a capillary blood fingerstick. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29163194 | Background | Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017. |
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Participants will each undergo all five treatments, in randomized order. The five treatments include the control placebo, 5g of KE1, 10g of KE1, 5g of KE4, and 10g of KE4. There will be a minimum of two days washout period between treatments.
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Supplement packaging will be labeled with an alphanumeric code that is only understood by an individual who is not involved in the study. The participants and study team will both be blinded to the supplement being given.
| KE1 10g |
| Dietary Supplement |
10g of KE1 (KetoneAid, Falls Church, VA), equal to 4 ounces |
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| KE4 5g | Dietary Supplement | 5g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces |
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| KE 10g | Dietary Supplement | 10g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces |
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| Placebo drink | Other | Flavor-matched control placebo drink (KetoneAid, Falls Church, VA), 4 ounces |
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