HealthyNCT05384106
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
A study testing (R)-1,3-butanediol in people with Healthy, run by Genomatica Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- (R)-1,3-butanediol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moniker Commons
San Diego, California, 92106
Vassili Kotlov, research@impactsciencealliance.org
About this study
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.
Read the 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
- Being tested
- (R)-1,3-butanediol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(R)-1,3-butanediolDietary supplement
Also called Avela
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
| Study group | Role | What they receive |
|---|---|---|
| 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]. Receives: Dietary Supplement: (R)-1,3-butanediol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
Secondary outcomes (2)
To assess GI symptomology
Modified visual analogue scale (mVAS) GI symptoms tool
Measured: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
To assess Sleepiness/alertness
Stanford Sleepiness Scale (SSS)
Measured: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start25 May 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genomatica Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384106
- Sponsor's protocol ID
- 1129
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05384106
- Acronym / sponsor ID
- 1129
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Genomatica Inc.Industry (pharma, biotech, devices)
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avela™ (R)-1,3-Butanediol | Experimental | Dietary Supplement: (R)-1,3-butanediol3 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]. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (R)-1,3-butanediolAlso: AvelaAvela™ (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 | Dietary supplement | Avela™ (R)-1,3-Butanediol |
Primary outcome
To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels)
Time frame: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood, Measurement Range: 0.1 - 8.0 mmol/L
2 secondary outcomes
To assess GI symptomology
Time frame: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
To assess Sleepiness/alertness
Time frame: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (R)-1,3-butanediol in people with Healthy, run by Genomatica Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Lowder, MD (619-387-7120, research@impactsciencealliance.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels) (time frame: 0, 30, 60, 90, 120, 180, 240, and 300 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.