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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05384106
• Other study ID #: 1129
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2022
• Source: Genomatica Inc.
• Contact: James Lowder, MD
• Phone: 619-387-7120
• Email: research[@]impactsciencealliance.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Moniker Commons	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Genomatica Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels)	ß-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood, Measurement Range: 0.1 - 8.0 mmol/L	0, 30, 60, 90, 120, 180, 240, and 300 minutes
Secondary	To assess GI symptomology	Modified visual analogue scale (mVAS) GI symptoms tool	0, 30, 60, 90, 120, 180, 240, and 300 minutes
Secondary	To assess Sleepiness/alertness	Stanford Sleepiness Scale (SSS)	0, 30, 60, 90, 120, 180, 240, and 300 minutes