RECRUITING

Impact of Foods on Bile Acids, Metabolites, and Inflammation

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

Dietary incorporation of pulse crops may be an effective way to lower unhealthy elevations in serum bile acids. These elevations play a direct role in promoting obesity-related diseases estimated to be present in about one third of the US adult population, including non-alcoholic fatty liver disease and type 2 diabetes. The overarching hypothesis for this study is that pulse consumption increases bile acid secretion and excretion, which will decrease toxicity linked to excess accumulation of bile in the liver, improve metabolism, and lower resulting levels of bile acids in the serum. In direct alignment with the USDA-AFRI Food, Safety, Nutrition, and Health priority to address obesity and related chronic disease with increased fruit and vegetable consumption and also with the American Pulse Association call to investigate the impact of regular pulse consumption on human physical well- being, the long-term research goal of this study is to establish effective and practical therapeutic strategies utilizing dietary incorporation of pulse crops to prevent or reverse obesity driven diseases. The specific objectives in this proposal are to: 1. determine the impact of acute lentil ingestion on serum postprandial bile acid responses and composition in a human cohort with obesity, and 2. determine the impact of daily lentil consumption for 12 weeks on serum fasting and postprandial bile acid concentrations and composition in an overweight or obese cohort with elevated postprandial triglycerides. This proposal is being submitted in response to the American Pulse Association commodity board sponsored topic of investigating the impact pulse crop consumption on health.

Official Title

Therapeutic Impacts of Dietary Pulses on Bile Acids

Quick Facts

Study Start:2022-02-24
Study Completion:2024-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05245357

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 - 65 years of age
  2. * Body Mass Index greater than 27 kg/m\^2
  1. * taking medication that will influence cholesterol, lipids, or inflammation
  2. * a gallbladder condition or have had the gallbladder removed
  3. * allergy to wheat, dairy, or legumes
  4. * pregnant or lactating
  5. * have been on a ketogenic or paleo diet in the past 6 weeks
  6. * have been on antibiotics in the past 90 days

Contacts and Locations

Study Contact

Mary P Miles, PhD
CONTACT
406-994-6678
mmiles@montana.edu

Principal Investigator

Mary P Miles, PhD
PRINCIPAL_INVESTIGATOR
Montana State University

Study Locations (Sites)

Nutrition Research Laboratory
Bozeman, Montana, 59717
United States

Collaborators and Investigators

Sponsor: Montana State University

  • Mary P Miles, PhD, PRINCIPAL_INVESTIGATOR, Montana State University

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 Date2022-02-24
Study Completion Date2024-05

Study Record Updates

Study Start Date2022-02-24
Study Completion Date2024-05

Terms related to this study

Additional Relevant MeSH Terms

  • Inflammation
  • Hypertriglyceridemia
  • Metabolic Disease
  • Lipid Metabolism Disorder
  • Hyperlipidemias
  • Bile Acid Malabsorption