Impact of Foods on Bile Acids, Metabolites, and Inflammation

NCT05245357 | Unknown

• 1 other identifier: AFRI Grant 2021-67028-34103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 1.determine the impact of acute lentil ingestion on serum postprandial bile acid responses and composition in a human cohort with obesity, and
2. 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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Postprandial Bile Acid Response to High-Fat Meal

  Area under the curve for bile acid concentration after consuming a meal containing 40g fat

  1 day

• Peak Bile Acid Response to High-Fat Meal

  Greatest change in bile acid concentration after consuming a meal containing 40g fat

  1 day

• Postprandial Triglyceride Response to High-Fat Meal

  Area under the curve for triglcyerides concentration after consuming a meal containing 40g fat

  1 day

• Peak Triglyceride Response to High-Fat Meal

  Greatest change in triglycerides concentration after consuming a meal containing 40g fat

  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

  Area under the curve for 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) concentrations after consuming a meal containing 40 g of fat

  1 day

• Postprandial Serum Metabolite Response (untargeted) to a High-Fat Meal

  Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis after consuming a meal containing 40g of fat

  1 day

• Fasting Serum Metabolite Response (untargeted) to a High-Fat Meal

  Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis before consuming a meal containing 40g of fat

  1 day

• Gut Microbiome Composition

  Relative abundance of operational taxonomic units of microbes measured from fecal samples

  1 day

Secondary Outcomes (6)

• Body Composition

  1 day

• Visceral Adipose Tissue

  1 day

• Body Mass Index

  1 day

• Habitual Diet

  1 month

• Acute Diet

  1 day

Study Arms (2)

Lentil, then Control

EXPERIMENTAL

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.

Behavioral: Lentil; Behavioral: Control

Control, then Lentil

EXPERIMENTAL

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.

Behavioral: Lentil; Behavioral: Control

Interventions

Lentil BEHAVIORAL

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

Control, then Lentil; Lentil, then Control

Control BEHAVIORAL

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

Control, then Lentil; Lentil, then Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Nutrition Research Laboratory

Bozeman, Montana, 59717, United States

RECRUITING

MeSH Terms

Conditions

Inflammation; Hypertriglyceridemia; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias

Interventions

lentil lectin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Nutritional and Metabolic Diseases

Study Officials

• Mary P Miles, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary P Miles, PhD

CONTACT

406-994-6678; mmiles@montana.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Lentil and Control meals were designed to be comparable in taste and appearance. The meals are prepared and coded prior to receipt by the research team. Randomization is for order of coded meals.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design is 2 x 2 crossover design, where the overweight and obese adults without Type 2 Diabetes will be randomized into Control or Lentil

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 17, 2022
• Study Start: February 24, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)