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

Status unconfirmed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT05384106

Run by

Genomatica Inc.

People needed

30

Starts

2022-05-25

Expected to finish

2022-06-30

Last updated by the study team

2022-05-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Moniker Commons — San Diego, California, United States

Full record on ClinicalTrials.gov

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