Inflammation Clinical Trial
Official title:
Therapeutic Impacts of Dietary Pulses on Bile Acids
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Nutrition Research Laboratory | Bozeman | Montana |
Lead Sponsor | Collaborator |
---|---|
Montana State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Peak Bile Acid Response to High-Fat Meal | Greatest change in bile acid concentration after consuming a meal containing 40g fat | 1 day | |
Primary | Postprandial Triglyceride Response to High-Fat Meal | Area under the curve for triglcyerides concentration after consuming a meal containing 40g fat | 1 day | |
Primary | Peak Triglyceride Response to High-Fat Meal | Greatest change in triglycerides concentration after consuming a meal containing 40g fat | 1 day | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Gut Microbiome Composition | Relative abundance of operational taxonomic units of microbes measured from fecal samples | 1 day | |
Secondary | Body Composition | % body fat | 1 day | |
Secondary | Visceral Adipose Tissue | Quantity of adipose in liters located within the abdominal compartment | 1 day | |
Secondary | Body Mass Index | kg of body mass per meter of height squared | 1 day | |
Secondary | Habitual Diet | Habitual dietary intake from past month reported through a food frequency questionnaire for food, beverage, and supplement intake | 1 month | |
Secondary | Acute Diet | Dietary intake from the last 24-hours, self-reported through a guided online prompt | 1 day | |
Secondary | Acute Physical Activity | Physical activities from the last 24-hours, self-reported through a guided online promoted | 1 day |
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