AN OPEN-LABEL, ACUTE CLINICAL TRIAL TO ASSESS THE LEVEL OF KETONE PRODUCTION FOLLOWING CONSUMPTION OF AVELA™ (R)-1,3-BUTANEDIOL IN AN ADULT POPULATION
Study Details
Study Description
Brief Summary
The purpose of the pilot clinical trial described herein is to determine the level of ketone production [measured as β hydroxybutyrate (BHB)] following consumption of (R)-1,3-butanediol in a beverage and to record gastrointestinal (GI) symptomology, as well as any effects on alertness/sleepiness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Primary:
To evaluate the level of production of BHB following the consumption of 3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [total intake of 34.5 g of (R)-1,3-butanediol].
BHB levels will be measured using capillary whole blood from the fingertips using at home Keto-Mojo monitoring system (β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood).
Measurement Range: 0.1 - 8.0 mmol/L Measurement time (min): 0, 30, 60, 90, 120, 180, 240, 300
Secondary:
To evaluate the acute effects of 3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [i.e., total intake of 34.5 g (R)-1,3-butanediol] on: GI tolerance.
All subjects will complete the mVAS GI symptoms tool at baseline (0 minutes), and at 30, 60, 90, 120, 180, 240, and 300 minutes.
A validated tool to measure GI tolerability of (R)-1,3-butanediol will be utilized. The mVAS GI symptoms tool is a self-administered questionnaire, which is modeled after the validated "gold standard" measurement tool predominantly used to test clinical gastroenterology scenarios (Bengtsson et al., 2013).
Sleepiness/alertness The SSS (Shahid et al., 2012) is a subjective tool to assess how alert a subject is feeling at specific moments in time. The scale requires respondents to select a rating of 1 to 7, where a "1" indicates the subject is "feeling active, vital, alert, or wide awake" and the highest score of "7" indicates the subject is "no longer fighting sleep, sleep onset soon; having dream-like thoughts" (Hoddes et al., 1973). The scale is validated, correlating r = 0.68 with performance on the Wilkinson tests. All subjects will complete the SSS at baseline (0 minutes) and at 30, 60, 90, 120, 180, 240, and 300 minutes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Avela™ (R)-1,3-Butanediol 3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [total intake of 34.5 g of (R)-1,3-butanediol]. |
Dietary Supplement: (R)-1,3-butanediol
Avela™ (R)-1,3-butanediol is intended to induce ketosis in the general adult population. Avela™ (R)-1,3-butanediol is GRAS for use in beverages, bars, and gels
Other Names:
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Outcome Measures
Primary Outcome Measures
- To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels) [0, 30, 60, 90, 120, 180, 240, and 300 minutes]
β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood, Measurement Range: 0.1 - 8.0 mmol/L
Secondary Outcome Measures
- To assess GI symptomology [0, 30, 60, 90, 120, 180, 240, and 300 minutes]
Modified visual analogue scale (mVAS) GI symptoms tool
- To assess Sleepiness/alertness [0, 30, 60, 90, 120, 180, 240, and 300 minutes]
Stanford Sleepiness Scale (SSS)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females, 18 to 65 years of age
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BMI 18 to <35.0 kg/m2, inclusive
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Weight ≥ 110 lbs
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Subject is judged to be in good health on the basis of medical history
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Subject is willing to fast for 12 hours prior to study start
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Subject is willing to avoid alcohol and intense physical activity the day prior to and on the day of testing
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Subject is capable of giving informed consent and complying with all study procedures/requirements.
Exclusion Criteria:
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Previous GI disorders (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, or gastroparesis)
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Gastroenteritis in the 2 weeks preceding the study
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Diabetes
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Weight <110 lbs
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History of alcohol or drug abuse
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Previous diagnosis of neurological disorders, depression, or mental illness with psychosis
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Unexplained alarm features (i.e., unintentional weight loss >10% body weight in the last 3 months, fevers, or blood in stools)
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Use of an antibiotic or any medication impacting gut transit during the 2 weeks before the study
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Constipation or diarrhea (defined as, on average, less than 3 stools per week or more than 3 stools per day, respectively)
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Allergy to tree nuts
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Women who are pregnant or breastfeeding
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Persons with medical conditions affecting the pancreas, liver, thyroid, or gall bladder.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moniker Commons | San Diego | California | United States | 92106 |
Sponsors and Collaborators
- Genomatica Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 1129