Dietary Fat MetabolismNCT06313606
Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ
A study of Dietary Fat Metabolism, run by University of California, Davis at 1 site in United States.
Trial summary
Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Fat Metabolism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to 26 Aug 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 50, with a Body Mass Index (BMI) categorized "normal" through "overweight" (18.5-29.9 kg/m2) and able to provide informed consent in English will be recruited to the study.
Who cannot join
- - pregnancy or lactation
- allergy or aversion to any of the foods that will be studied and/or provided
- history of gastrointestinal disorders including ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer (HNPCC), familial adenomatous polyposis, pancreatic disease, or liver disease
- history of any metabolic diseases (including, but not limited to: diabetes mellitus, hyperlipidemia)
- previous gastrointestinal resection or bariatric surgery
- bleeding disorders that preclude blood draws
Show all 20Show fewer
- history of kidney disease
- recent hospital admissions (past 6 months) for heart disease (MI/CVA or CHF) or other CVD/CAD conditions under physician guided therapy
- cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment
- regular alcohol intake of > 2 drinks/day (equivalent to 720 mL of beer, 240 mL of wine, or 90 mL of spirits) and unwilling to abstain during the run-in week and test day
- use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vapes, etc.) and not willing to abstain during the run-in week and test day
- use of illicit drugs and not willing to abstain during the run-in week and test day
- BMI greater than 30 kg/m2 or below 18.5 kg/m2
- regular (daily to weekly) use of over the counter (OTC) weight-loss aids, anti-acids or anti-inflammatories, and unwilling or unable to stop taking during the run-in week and test day
- regular OTC dietary supplements that interfere with the test foods being studied including pills, chewables, liquids or powders for the following: fiber, fish oil (including cod liver oil), probiotics, and unwilling or unable to stop taking during the run-in week and test day
- oral or IV antibiotic use in the past 6 months (could defer participation until 6 months post-completion of course of antibiotics)
- seated blood pressure >140/90 mmHg
- fasting clinical lab tests outside acceptable values as ascertained at the screening blood draw
- current use of specific prescription medication(s) that could impact gut physiology, gut microbiota, or other systems relevant to metabolism and fat PK
- inability to freely give informed consent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis School of Medicine
Sacramento, California, 95817
About this study
Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Some of these lipids appear to have signaling properties in the body's tissues, i.e., to help regulate cardiometabolic health. Thus, increasing the bioavailability of CpFAs in humans may have utility to improve management of blood sugar and blood lipids, or to mitigate or prevent non-alcoholic fatty liver disease (NAFLD). This study is a proof-of-principle experiment in 10 subjects, to feed dietary fats thought to enhance upper gut CpFA production. The latter will be monitored through post-meal blood and urine CpFA concentration measurements, as well as concentration in the stool.
- Conditions
- Dietary Fat Metabolism
- Being tested
- Dietary fat positive control, Dietary fat negative control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fat positive controlDietary supplement
Dietary fat-containing meal plan with a specific supplement that may modify fat metabolism
Dietary fat negative controlDietary supplement
Dietary fat-containing meal plan with a specific supplement that should not modify fat metabolism
| Study group | Role | What they receive |
|---|---|---|
| Dietary fat with negative control supplement | Experimental | Dietary fat-containing meal plan with a specific supplement that should not modify fat metabolism Receives: Dietary Supplement: Dietary fat negative control |
| Dietary fat with positive control supplement | Experimental | Dietary fat-containing meal plan with a specific supplement that may modify fat metabolism Receives: Dietary Supplement: Dietary fat positive control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool
Change in blood, urine, or gastrointestinal (stool) CpFA fatty acids following dietary fat intake
Measured: 24-48 hours following test meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start21 May 2024
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary Fat MetabolismStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean H. Adams, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313606
- Sponsor's protocol ID
- 2047436
- Status last verified
- May 2026
- First submitted
- 23 Sep 2023
- Last updated
- 11 May 2026
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ
- ClinicalTrials.gov ID
- NCT06313606
- Acronym / sponsor ID
- 2047436
- Conditions
- Dietary Fat Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 15 Mar 2024 (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.
Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Some of these lipids appear to have signaling properties in the body's tissues, i.e., to help regulate cardiometabolic health. Thus, increasing the bioavailability of CpFAs in humans may have utility to improve management of blood sugar and blood lipids, or to mitigate or prevent non-alcoholic fatty liver disease (NAFLD). This study is a proof-of-principle experiment in 10 subjects, to feed dietary fats thought to enhance upper gut CpFA production. The latter will be monitored through post-meal blood and urine CpFA concentration measurements, as well as concentration in the stool.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary fat with negative control supplement | Experimental | Dietary Supplement: Dietary fat negative controlDietary fat-containing meal plan with a specific supplement that should not modify fat metabolism |
| Dietary fat with positive control supplement | Experimental | Dietary Supplement: Dietary fat positive controlDietary fat-containing meal plan with a specific supplement that may modify fat metabolism |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women aged 18 to 50, with a Body Mass Index (BMI) categorized "normal" through "overweight" (18.5-29.9 kg/m2) and able to provide informed consent in English will be recruited to the study.
Key exclusion criteria (20 listed)
- - pregnancy or lactation
- allergy or aversion to any of the foods that will be studied and/or provided
- history of gastrointestinal disorders including ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer (HNPCC), familial adenomatous polyposis, pancreatic disease, or liver disease
- history of any metabolic diseases (including, but not limited to: diabetes mellitus, hyperlipidemia)
- previous gastrointestinal resection or bariatric surgery
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 |
|---|---|---|
| Dietary fat positive controlDietary fat-containing meal plan with a specific supplement that may modify fat metabolism | Dietary supplement | Dietary fat with positive control supplement |
| Dietary fat negative controlDietary fat-containing meal plan with a specific supplement that should not modify fat metabolism | Dietary supplement | Dietary fat with negative control supplement |
Primary outcome
Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool
Time frame: 24-48 hours following test meal intake
Change in blood, urine, or gastrointestinal (stool) CpFA fatty acids following dietary fat intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- 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.
Sean H. Adams, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dietary Fat Metabolism, run by University of California, Davis 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 1 inclusion and 20 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: finished, as of the sponsor's last update on 11 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool (time frame: 24-48 hours following test meal intake). 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 11 May 2026.