Impact of Foods on Bile Acids, Metabolites, and Inflammation
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.
Conditions:
🦠 Inflammation 🦠 Hypertriglyceridemia 🦠 Metabolic Disease 🦠 Lipid Metabolism Disorder 🦠 Hyperlipidemias 🦠 Bile Acid Malabsorption
🗓️ Study Start (Actual) 24 February 2022
🗓️ Primary Completion (Estimated) May 2024
✅ Study Completion (Estimated) May 2024
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bozeman, Montana, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 18 - 65 years of age
    • * Body Mass Index greater than 27 kg/m\^2

    Exclusion Criteria:

    • * taking medication that will influence cholesterol, lipids, or inflammation
    • * a gallbladder condition or have had the gallbladder removed
    • * allergy to wheat, dairy, or legumes
    • * pregnant or lactating
    • * have been on a ketogenic or paleo diet in the past 6 weeks
    • * have been on antibiotics in the past 90 days
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 31 January 2022
  • First Submitted that Met QC Criteria 15 February 2022
  • First Posted 17 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 May 2023
  • Last Update Posted 6 May 2023
  • Last Verified May 2023