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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: (R)-1,3-butanediol

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Lowder, MD; Phone Number: 619-387-7120; Email: research@impactsciencealliance.org
• Study Contact Backup: Name: Vassili Kotlov; Phone Number: 619-387-7120; Email: research@impactsciencealliance.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92106
      • Moniker Commons
      • Contact: Vassili Kotlov; Email: research@impactsciencealliance.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Avela

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels)	β-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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess GI symptomology	Modified visual analogue scale (mVAS) GI symptoms tool	0, 30, 60, 90, 120, 180, 240, and 300 minutes
To assess Sleepiness/alertness	Stanford Sleepiness Scale (SSS)	0, 30, 60, 90, 120, 180, 240, and 300 minutes

Collaborators and Investigators

• Sponsor: Genomatica Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 25, 2022
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No