Enhancing gut bacteria to produce beneficial fats
Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ
This study is testing whether certain dietary fats can help improve gut bacteria to produce beneficial fats that might help with blood sugar and heart health in people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06313606 on ClinicalTrials.gov |
What this trial studies
This study investigates how dietary fats can stimulate the production of long-chain cyclopropane fatty acids (CpFAs) in the gut, which may play a role in regulating blood sugar and lipids. It involves a proof-of-principle experiment with 10 participants who will consume specific dietary fats believed to enhance CpFA production. The researchers will monitor CpFA levels in blood, urine, and stool after meals to assess the effectiveness of the dietary interventions. The goal is to explore the potential of CpFAs in improving cardiometabolic health and preventing conditions like non-alcoholic fatty liver disease.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18 to 50 with a normal to overweight BMI.
Not a fit: Patients with metabolic diseases, gastrointestinal disorders, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary strategies for managing blood sugar and lipid levels, potentially reducing the risk of metabolic diseases.
How similar studies have performed: While the specific approach of enhancing gut bacteria for CpFA production is novel, related studies on dietary fats and metabolic health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * - 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 * 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
Where this trial is running
Sacramento, California
- University of California, Davis School of Medicine — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Sean H. Adams, PhD — University of California, Davis
- Study coordinator: Sean H. Adams, PhD
- Email: shadams@ucdavis.edu
- Phone: 916-734-4868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.