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

NCT05384106 | Unknown

• 1 other identifier: 1129
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To assess GI symptomology

  0, 30, 60, 90, 120, 180, 240, and 300 minutes

• To assess Sleepiness/alertness

  0, 30, 60, 90, 120, 180, 240, and 300 minutes

Study Arms (1)

Avela™ (R)-1,3-Butanediol

EXPERIMENTAL

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

Interventions

(R)-1,3-butanediol 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

Also known as: Avela

Avela™ (R)-1,3-Butanediol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genomatica Inc.: lead

Study Sites (1)

Moniker Commons

San Diego, California, 92106, United States

Location

Central Study Contacts

James Lowder, MD

CONTACT

619-387-7120; research@impactsciencealliance.org

Vassili Kotlov

CONTACT

619-387-7120; research@impactsciencealliance.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 20, 2022
• Study Start: May 25, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)