Completed

NCT Number: NCT06313606

Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ

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.

Completed

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Key information

Conditions

Dietary Fat Metabolism

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis School of Medicine

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary fat positive control

Dietary Supplement

Dietary fat-containing meal plan with a specific supplement that may modify fat metabolism

Dietary fat negative control

Dietary Supplement

Dietary fat-containing meal plan with a specific supplement that should not modify fat metabolism

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Mar 15, 2024
Registry last updated: May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.