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The purpose of this study is to examine how the body absorbs, digests, and metabolizes three different investigational ketone dietary supplements (ketone monoester, ketone tri-ester, ketone salt) and to assess gastrointestinal tolerance or other adverse effects. This study is considered investigational because data are being collected on the differences over time between three active study products. Consumption of these study products are not intended to diagnose, treat, cure, or prevent any disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12.5mg Ketone Tri Ester | Active Comparator | Dietary Supplement containing Tri-betahydroxybutyrin |
|
| 12.5mg Ketone Mono Ester | Active Comparator | Dietary Supplement containing a ketone mono Ester |
|
| 12.5mg Ketone Salt | Active Comparator | Dietary supplement containing a ketone salt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement containing Tri-betahydroxybutyrin | Dietary Supplement | Ketone Tri Ester |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum BHB concentration maximum (Cmax) | blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product | |
| time to maximum concentration (Tmax) | blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product | |
| area under the curve (AUC), | blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product | |
| elimination half-life (T1/2), | blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product | |
| oral clearance | blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product | |
| volume of distribution | blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for GI tolerance | assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product | |
| Safety (vital signs) and Adverse Events | assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product |
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Inclusion Criteria:
• Provide voluntary signed and dated informed consent.
Exclusion Criteria:
Individuals using any kind of GLP-1 medications.
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| Name | Affiliation | Role |
|---|---|---|
| Tim Ziegenfuss, PhD | CAHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAHS | Canfield | Ohio | 44406 | United States |
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| Dietary Supplement containing a ketone mono Ester | Dietary Supplement | Ketone Mono Ester |
|
| Dietary supplement containing a ketone salt | Dietary Supplement | Dietary Supplement from a ketone salt |
|