Recruiting

Observational Study

Sponsor:

Montana State University

Code:

NCT05245357

Conditions

Inflammation

Hypertriglyceridemia

Metabolic Disease

Lipid Metabolism Disorder

Hyperlipidemias

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Lentil

Control

Study Details

Brief 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

Study ID

NCT05245357

Start date

Feb 24, 2022

Status verified date

May, 2023

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Lentil, then Control

Participants first received a meal with 140 g of lentils in the morning. After a washout period of at least 7 days, they then received a meal with 0 g of lentils in the morning.

experimental: Control, then Lentil

Participants first received a meal with 0 g of lentils in the morning. After a washout period of at least 7 days, they then received a meal with 140 g of lentils in the morning.

Interventions

Lentil

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

Control

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

Primary outcome measure

  • Postprandial Bile Acid Response to High-Fat Meal [ Time Frame: 1 day ]
  • Peak Bile Acid Response to High-Fat Meal [ Time Frame: 1 day ]
  • Postprandial Triglyceride Response to High-Fat Meal [ Time Frame: 1 day ]
  • Peak Triglyceride Response to High-Fat Meal [ Time Frame: 1 day ]
  • Postprandial Serum Inflammatory Cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) Response to High-fat Meal [ Time Frame: 1 day ]
  • Postprandial Serum Metabolite Response (untargeted) to a High-Fat Meal [ Time Frame: 1 day ]
  • Fasting Serum Metabolite Response (untargeted) to a High-Fat Meal [ Time Frame: 1 day ]
  • Gut Microbiome Composition [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

Nutrition Research Laboratory

Recruiting

Bozeman, Montana, United States, 59717

Contacts

More Information

Sponsor

Montana State University

Last update posted

May 6, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montana State University on 2023-05-06.