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Impacts of Lentils on Metabolism and Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283448
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Montana State University

Brief Summary:

The overall goal of this investigation is to determine gut microbiome dependent and independent impacts of pulse consumption on metabolic resilience and metabolic risk profiles for type 2 diabetes (T2D) and cardiovascular disease (CVD) risk. Specifically, pulse crop consumption has unrealized potential to fundamentally alter how the body responds to disease promoting metabolic stresses of postprandial triglyceride and inflammation responses. The specific objectives are to (1) Determine the impact of green lentil consumption on postprandial triglyceride (TG) and inflammation responses to a high-fat meal challenge. (2) Determine the extent to which the gut microbiome and changes in the gut microbiome induced by pulse consumption influence health impacts (3) Measure metabolomic profiles to elucidate underlying mechanisms linking pulse consumption to improved health. To achieve these objectives investigators will determine the effects of green lentil on high impact risk factors of large postprandial triglyceride excursions and inflammation, composition of and changes in the gut microbiomes, and both gut and serum metabolomes in overweight/obese (OW/OB) individuals with elevated risk. The 12-week intervention will consist of consumption of 4.6 or 0 cups of pulses per week across 7 pre-made meals (matched for macronutrient content (except fiber) provided to experimental and control groups. The following hypotheses will be tested in the proposed investigation:

H1: Lentil consumption lower postprandial TG and inflammation responses and improve overall metabolic health.

H2: Characteristics of the gut microbiome and changes in the gut microbiome induced by lentil consumption substantially influence health impacts of pulse consumption.

H3: Features of the fecal and serum metabolomes distinguishing lentil and control treatments correspond to metabolic pathways elucidating potential gut microbiome dependent and independent mechanisms linking pulse consumption to improved health.


Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Inflammation Waist, Hypertriglyceridemic Behavioral: Dietary Lentil Behavioral: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will utilize a parallel intervention of meals with 0.66 cups of lentils each day versus macronutrient-matched (not including fiber) meals with 0 cups of lentils each day for 12 weeks in OW/OB adults with demonstrated risk for T2D and CVD.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gut Microbiota Dependent and Independent Impacts of Dietary Pulses on Pre- and Postprandial Metabolism and Inflammation in Overweight/Obese Humans
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Lentil
0.66 cups lentils
Behavioral: Dietary Lentil
Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.

Sham Comparator: Control
0.0 cups lentils
Behavioral: Control
Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.




Primary Outcome Measures :
  1. Postprandial Serum Triglyceride Response to High-fat Meal [ Time Frame: 12 weeks ]
    Area under the curve for triglyceride concentration after consuming a meal containing 50 g of fat

  2. Peak Serum Triglyceride Response to High-fat Meal [ Time Frame: 12 weeks ]
    Greatest change in triglyceride concentration after consuming a meal containing 50 g of fat

  3. 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: 12 weeks ]
    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 50 g of fat

  4. Peak 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: 12 weeks ]
    Greatest change in 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) concentration after consuming a meal containing 50 g of fat

  5. Gut Microbiome Composition [ Time Frame: 12 weeks ]
    Relative abundance (operational taxonomic units/10,000 reads) of microbial taxa measured from fecal samples

  6. Postprandial Serum Metabolite (untargeted) Response to High-fat Meal [ Time Frame: 12 weeks ]
    Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis after consuming a meal containing 50 g of fat

  7. Fasting serum triglycerides [ Time Frame: 12 weeks ]
    Concentration of triglycerides in the serum after an overnight fast

  8. Fasting 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) levels [ Time Frame: 12 weeks ]
    Concentration of inflammatory cytokines (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) in the serum after an overnight fast

  9. Fasting serum metabolites (untargeted) [ Time Frame: 12 weeks ]
    Concentration of metabolites in the serum after an overnight fast


Secondary Outcome Measures :
  1. Body Composition [ Time Frame: 12 weeks ]
    % body fat

  2. Visceral Adipose Tissue [ Time Frame: 12 weeks ]
    Quantity of adipose in liters located within the abdominal compartment

  3. Blood Pressure [ Time Frame: 12 weeks ]
    Systolic and Diastolic blood pressure measured in mmHg

  4. Body mass index [ Time Frame: 12 weeks ]
    kg of mass per meter of height squared

  5. Perceptions of Hunger, Fullness, Satiety, and Satisfaction after Mid-day Meal [ Time Frame: 12 weeks ]
    Ratings (1=lowest, 10=highest) of hunger, fullness, satiety, and satisfaction in response to mid-day meal

  6. Gastrointestinal Symptoms of Bloating, Cramping, Discomfort, and Flatulence [ Time Frame: 12 weeks ]
    Qualitative ratings (none, mild, moderate, high) of gastrointestinal bloating, cramping, discomfort, and flatulence


Other Outcome Measures:
  1. Physical Activity [ Time Frame: 7 days ]
    Time spent in low, moderate-to-vigorous, and vigorous physical activity per day

  2. Diet [ Time Frame: 12 months ]
    Habitual dietary intake reported through a food frequency questionnaire for food intake



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Waist circumference > 35 inches for women and > 40 inches for men
  • Non-fasting serum triglyceride concentration > 175 mg/dl

Exclusion Criteria:

  • Allergy to wheat
  • Taking medication that will influence cholesterol, lipids, or inflammation
  • Pregnant
  • Have diabetes, a pacemaker, or other health conditions that may interfere with the study outcomes
  • Planning to undergo a weight loss intervention or change in exercise regimen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283448


Contacts
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Contact: Mary P Miles, PhD 1-406-994-6678 mmiles@montana.edu
Contact: Colleen R McMilin, PhD 1-406-994-6369 colleen.mcmilin@montana.edu

Locations
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United States, Montana
Nutrition Research Laboratory Recruiting
Bozeman, Montana, United States, 59717
Contact: Mary P Miles, PhD    406-994-6678    mmiles@montana.edu   
Contact: Stephanie M Wilson, MS    406-994-5001    stephanie.keene@montana.edu   
Sponsors and Collaborators
Montana State University
Investigators
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Principal Investigator: Mary Miles, PhD Montana State University
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Responsible Party: Montana State University
ClinicalTrials.gov Identifier: NCT04283448    
Other Study ID Numbers: 58-3060-9-040
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hypertriglyceridemic Waist
Inflammation
Pathologic Processes
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Signs and Symptoms