Healthy
Conditions
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.
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.
Interventions
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
Sponsors
Genomatica Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
Primary ContactJames Lowder, MD
Backup ContactVassili Kotlov
Outcome results
None listed