Status:
UNKNOWN
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
Lead Sponsor:
Genomatica Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
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 beverag...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05384106
Start Date
May 25 2022
End Date
June 30 2022
Last Update
May 20 2022
Active Locations (1)
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1
Moniker Commons
San Diego, California, United States, 92106