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| ID | Type | Description | Link |
|---|---|---|---|
| BIO-2103 | Other Identifier | Biofortis |
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The objective of this study is to capture information on tolerance and safety of a ketone-promoting food ingredient in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone-Promoting Food Ingredient 1 | Experimental | Novel ketone-promoting food ingredient (#1) administered in a beverage once daily for 28 days. |
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| Ketone Free Placebo | Placebo Comparator | Beverage matched for appearance, volume, taste and texture to experimental arm (ketone promoting food ingredient #1) that does NOT contain a ketone ingredient. Consumed once daily for 28 days. |
|
| Ketone-Promoting Food Ingredient 2 | Active Comparator | Previously characterized ketone-promoting food ingredient (#2) administered in a beverage once daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone- Promoting Food Ingredient #1 | Other | Novel proprietary food ingredient (#1) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term tolerance of ketone promoting food ingredient #1 | Difference between experimental arm (ketone promoting food ingredient #1) vs placebo in composite score of tolerance, assessed by twice daily tolerance questionnaires completed at home. Subjects complete a tolerance questionnaire twice daily, to assess the presence of 10 symptoms before and 4-6h after consuming the study beverage. Questionnaire ranks severity (None, mild, moderate, severe) and incidence (usually, somewhat more than usual, much more than usual). Answers are assigned a numerical value, where higher score is a greater severity and incidence of symptoms. The difference is calculated between the pre- and post- beverage questionnaire for a daily score. Daily scores for the duration of the study are added together to give a single composite score for the whole study period. | Day From baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute tolerance of ketone promoting food ingredient #1 | Difference between experimental arm (ketone promoting food ingredient #1) vs placebo in composite scores of tolerability, assessed by a tolerance questionnaire at 1h after beverage consumption at clinic visits. Subjects complete a tolerance questionnaire twice, to assess the presence of 10 symptoms before and 1h after consuming the study beverage. Questionnaire ranks severity (None, mild, moderate, severe) and incidence (usually, somewhat more than usual, much more than usual). Answers are assigned a numerical value, where higher score is a greater severity and incidence of symptoms. The difference is calculated between the pre- and post- beverage questionnaire for a score representing acute tolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term tolerance of ketone promoting food ingredient #2 | Difference between active comparator arm (ketone promoting food ingredient #2) vs placebo in composite score of tolerance, assessed by twice daily tolerance questionnaires completed at home. Subjects complete a tolerance questionnaire twice daily, to assess the presence of 10 symptoms before and 4-6h after consuming the study beverage. Questionnaire ranks severity (None, mild, moderate, severe) and incidence (usually, somewhat more than usual, much more than usual). Answers are assigned a numerical value, where higher score is a greater severity and incidence of symptoms. The difference is calculated between the pre- and post- beverage questionnaire for a daily score. Daily scores for the duration of the study are added together to give a single composite score for the whole study period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Beckman, MD | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Addison | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23078583 | Background | Rueger SY, King AC. Validation of the brief Biphasic Alcohol Effects Scale (B-BAES). Alcohol Clin Exp Res. 2013 Mar;37(3):470-6. doi: 10.1111/j.1530-0277.2012.01941.x. Epub 2012 Oct 18. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 25, 2023 | |
| Reset | Mar 6, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 25, 2023 | Mar 6, 2024 |
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| Ketone- Promoting Food Ingredient #2 | Other | Previously characterized proprietary food ingredient (#2) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage. |
|
| Ketone Free Placebo | Other | Beverage that is matched to ketone-promoting food ingredient #1 beverage for appearance, taste, texture and volume. Does not contain ketones or ketone precursors. |
|
| Days 0, 7 and 14 |
| Subjective Arousal after ketone promoting food ingredient #1 | Difference between experimental arm (ketone promoting food ingredient #1) vs placebo in the composite scores of the stimulatory and sedative subscale using the Brief Biphasic Alcohol Effect Scale (B-BAES); completed twice daily at home. B-BAES presents 6 items in alphabetical order, and subjects rank them on an 11 point scale, from 0 = not at all to 10 = extremely. The difference is calculated between the pre- and post- beverage questionnaire for a daily score. Daily scores for the duration of the study are added together to give a single composite score for the whole study period. Rueger, S. Y. and A. C. King (2013). "Validation of the brief Biphasic Alcohol Effects Scale (B-BAES)." Alcohol Clin Exp Res 37(3): 470-476. | From baseline to Day 28 |
| Safety Blood Profile | Change from baseline Day 28 in the incidence of abnormal laboratory test results | From baseline to Day 28 |
| From baseline to Day 28 |
| Acute tolerance of ketone promoting food ingredient #2 | Difference between active comparator arm (ketone promoting food ingredient #2) vs placebo in composite scores of tolerability, assessed by a tolerance questionnaire at 1h after beverage consumption at clinic visits. Subjects complete a tolerance questionnaire twice, to assess the presence of 10 symptoms before and 1h after consuming the study beverage. Questionnaire ranks severity (None, mild, moderate, severe) and incidence (usually, somewhat more than usual, much more than usual). Answers are assigned a numerical value, where higher score is a greater severity and incidence of symptoms. The difference is calculated between the pre- and post- beverage questionnaire for a score representing acute tolerance. | Days 0, 7 and 14 |
| Subjective Arousal after ketone promoting food ingredient #2 | Difference between active comparator arm (ketone promoting food ingredient #2) vs placebo in the composite scores of the stimulatory and sedative subscale using the Brief Biphasic Alcohol Effect Scale (B-BAES); completed twice daily at home. B-BAES presents 6 items in alphabetical order, and subjects rank them on an 11 point scale, from 0 = not at all to 10 = extremely. The difference is calculated between the pre- and post- beverage questionnaire for a daily score. Daily scores for the duration of the study are added together to give a single composite score for the whole study period. Rueger, S. Y. and A. C. King (2013). "Validation of the brief Biphasic Alcohol Effects Scale (B-BAES)." Alcohol Clin Exp Res 37(3): 470-476. | From baseline to Day 28 |