RECRUITING

Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ

Quick Facts

Study Start:2024-04-01
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06313606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * - pregnancy or lactation
  2. * allergy or aversion to any of the foods that will be studied and/or provided
  3. * 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
  4. * history of any metabolic diseases (including, but not limited to: diabetes mellitus, hyperlipidemia)
  5. * previous gastrointestinal resection or bariatric surgery
  6. * bleeding disorders that preclude blood draws
  7. * history of kidney disease
  8. * recent hospital admissions (past 6 months) for heart disease (MI/CVA or CHF) or other CVD/CAD conditions under physician guided therapy
  9. * cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment
  10. * 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
  11. * 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
  12. * use of illicit drugs and not willing to abstain during the run-in week and test day
  13. * BMI greater than 30 kg/m2 or below 18.5 kg/m2
  14. * 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
  15. * 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
  16. * oral or IV antibiotic use in the past 6 months (could defer participation until 6 months post-completion of course of antibiotics)
  17. * seated blood pressure \>140/90 mmHg
  18. * fasting clinical lab tests outside acceptable values as ascertained at the screening blood draw
  19. * current use of specific prescription medication(s) that could impact gut physiology, gut microbiota, or other systems relevant to metabolism and fat PK
  20. * inability to freely give informed consent in English

Contacts and Locations

Study Contact

Sean H. Adams, PhD
CONTACT
916-734-4868
shadams@ucdavis.edu

Principal Investigator

Sean H. Adams, PhD
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, Davis

  • Sean H. Adams, PhD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Dietary Fat Metabolism