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

Conditions: Healthy

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.

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.

Eligibility criteria:
inclusion criteria: * males and females, 18 to 65 years of age * bmi 18 to \<35.0 kg/m2, inclusive * weight ≥ 110 lbs * subject is judged to be in good health on the basis of medical history * subject is willing to fast for 12 hours prior to study start * subject is willing to avoid alcohol and intense physical activity the day prior to and on the day of testing * subject is capable of giving informed consent and complying with all study procedures/requirements. exclusion criteria: * previous gi disorders (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, or gastroparesis) * gastroenteritis in the 2 weeks preceding the study * diabetes * weight \<110 lbs * history of alcohol or drug abuse * previous diagnosis of neurological disorders, depression, or mental illness with psychosis * unexplained alarm features (i.e., unintentional weight loss \>10% body weight in the last 3 months, fevers, or blood in stools) * use of an antibiotic or any medication impacting gut transit during the 2 weeks before the study * constipation or diarrhea (defined as, on average, less than 3 stools per week or more than 3 stools per day, respectively) * allergy to tree nuts * women who are pregnant or breastfeeding * persons with medical conditions affecting the pancreas, liver, thyroid, or gall bladder.