Impact of Foods on Bile Acids, Metabolites, and Inflammation

NCT05245357 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-06

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Lentil

Participants in the lentil arm of the study will consume a meal containing 140 g of lentils for breakfast one morning.

BEHAVIORAL

Control

Participants in the control arm of the study will consume a meal containing 0 g of lentils for breakfast one morning.

Sponsors & Collaborators

  • Montana State University

    lead OTHER

Principal Investigators

  • Mary P Miles, PhD · Montana State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245357 on ClinicalTrials.gov