Impact of Foods on Bile Acids, Metabolites, and Inflammation

Status unconfirmed · Not applicable

Conditions studied: Inflammation, Hypertriglyceridemia, Metabolic Disease, Lipid Metabolism Disorder, Hyperlipidemias, Bile Acid Malabsorption

In brief

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.

Key facts

Study ID

NCT05245357

Run by

Montana State University

People needed

24

Starts

2022-02-24

Expected to finish

2024-05-01

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Nutrition Research Laboratory — Bozeman, Montana, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.