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.

Study Overview

• Status: Completed
• Conditions: Dietary Fat Metabolism
• Intervention / Treatment: Dietary supplement: Dietary fat negative control; Dietary supplement: Dietary fat positive control

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary fat with negative control supplement; Dietary fat-containing meal plan with a specific supplement that should not modify fat metabolism	Dietary supplement: Dietary fat negative control; Dietary fat-containing meal plan with a specific supplement that should not modify fat metabolism
Experimental: Dietary fat with positive control supplement; Dietary fat-containing meal plan with a specific supplement that may modify fat metabolism	Dietary supplement: Dietary fat positive control; Dietary fat-containing meal plan with a specific supplement that may modify fat metabolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool	Change in blood, urine, or gastrointestinal (stool) CpFA fatty acids following dietary fat intake	24-48 hours following test meal intake

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Sean H. Adams, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Actual): August 26, 2024
• Study Completion (Actual): August 26, 2024

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2047436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No