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

NCT ID: NCT05384106

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2022-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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 \[total intake of 34.5 g of (R)-1,3-butanediol\].

Group Type: EXPERIMENTAL

(R)-1,3-butanediol

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

(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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Avela

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genomatica Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Moniker Commons

San Diego, California, United States

Countries

United States

Central Contacts

James Lowder, MD

Role: CONTACT

research@impactsciencealliance.org

619-387-7120

Vassili Kotlov

Role: CONTACT

research@impactsciencealliance.org

619-387-7120

Facility Contacts

Vassili Kotlov

Role: primary

research@impactsciencealliance.org

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1129

Identifier Type: -

Identifier Source: org_study_id