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Pulses Consumption and Its Role in Managing Systemic Inflammation, Insulin Sensitivity and Gut Microbiome in Human (PS)

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: NCT04267705
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Clinical Nutrition Research Center, Illinois Institute of Technology

Brief Summary:

Objective 1: Characterize indices of systemic inflammation and gut microbiota composition and function after chronic (12 weeks) intake of pulses compared to control diet in human OW/OB-IR participants.

Objective 2: Characterize dietary- and microbial-derived metabolite pools after regular intake of pulses (12 weeks) in human participants with OW/OB-IR compared to control diet.

Objective 3: Characterize cognitive functioning after chronic (12 weeks) intake of pulses compared to control diet in human OW/OB-IR participants.


Condition or disease Intervention/treatment Phase
Insulin Sensitivity Overweight or Obesity Inflammatory Response Other: Control Other: Black bean Other: Chickpea Not Applicable

Detailed Description:

The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.

The proposed study is a randomized, 3-arm, parallel, placebo-controlled design to investigate the effects of pulses consumption compared to non-pulse foods on indices of systemic inflammation and gut microbiota composition and function over a 12-week period. Potential changes in cognition will also be assessed. The study will test 3 treatment conditions in overweight (OW)/obese (OB) human subjects with insulin resistant (IR). Eighty-three men and women will be recruited, aiming for a completer set of Sixty-six subjects. Participants will be randomized into one of the three study food intervention groups:

  1. Control group, (n=22): This group will receive a cup of white rice 7 days/week over a 12-week period.
  2. Black bean group, (n=22): This group will receive a cup of black bean 7 days/week over a 12-week period.
  3. Chickpea group, (n=22): This group will receive a cup of chickpea 7 days/week over a 12-week period.

Each subject will be asked to come for 1 Screening Visit, 4 biweekly food pick-up/compliance visits and 3 Test Day Visits (two of which will also include cognitive testing). The initial screening visit will provide subjects with their site-specific, IRB-approved informed consent document prior to the start of any study-related procedures. Following 1-week diet stabilization and wash in from anthocyanins and ellagitannins, eligible subjects will be randomized to receive 1 of 3 test treatments based on a randomization schedule. The three main Test Day visits will occur at week 0 (day 1; baseline), end of week 6 (mid-point) and at the end of week 12 (end-point). Cognitive testing will occur during the baseline Test Day at week 0, and again at end-point Test Day at week 12. Subjects will be given a breakfast meal before cognitive testing. Pick-up Visits will occur at week 2, 4, 8, and 10. Subjects will pick-up study foods receive dietary counseling, confirm diet compliance and have anthropometrics checked during pick-up visits. Each of the 3 Test Day Visits will last about 2.5-3 h (not including cognitive testing) and involve blood pressure (BP) measurements, anthropometric (weight, waist circumference; body composition) assessment, and an oral glucose tolerance test (OGTT) will be performed. Urine and fecal samples will be collected to monitor modifications occurring in the metabolites during the supplementation. The two-Test Day Visits (baseline and end-point) will also include an additional 1-1.25 h of cognitive testing, for a total of 3.75-4.5 h of total subject time (as there will be a short break between OGTT and cognitive testing). Subjects will maintain daily food and GI-tract diary during the 12-week feeding trial. The diary will include questions about food intake and the condition of gastrointestinal tolerance and bowel function.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The proposed study is a randomized, 3-arm, parallel, placebo-controlled design
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Understanding the Pulse-Gut Relationship and it's Role in Modifying Systemic Inflammation and Insulin Sensitivity in Humans
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Black bean
A cup of black bean 7 days/week over a 12-week period
Other: Black bean
This group will receive a cup of black bean7 days/week over a 12-week period

Active Comparator: Chickpea
A cup of chickpea 7 days/week over a 12-week period
Other: Chickpea
This group will receive a cup of chick pea 7 days/week over a 12-week period

Placebo Comparator: Control
A cup of white rice 7 days/week over a 12-week period
Other: Control
This group will receive a cup of rice 7 days/week over a 12-week period




Primary Outcome Measures :
  1. Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB [ Time Frame: Baseline to 12 weeks ]
    Investigate Nrf2/ NF-κB activation in PBMC

  2. Changes in plasma systemic and gut inflammatory markers [ Time Frame: Baseline to 12 weeks ]
    Collected plasma samples will be used to measure selected inflammatory markers (IL6, hs-CRP and TNF-α) using ELISA methods

  3. Determination of GLP-2 in plasma [ Time Frame: Baseline to 12 weeks ]
    Analysis of GLP-2 will be done in plasma samples before and after chronic exposure to the study foods using enzyme Immunoassay (EIA) kit as per manufacturer's instructions.

  4. Determination of TLR-2/4 gene expression in Human PBMC [ Time Frame: Baseline to 12 weeks ]
    Determination of TLR-2/4 gene expression in Human PBMC using RT-PCR method

  5. Gut inflammatory markers: Calprotectin, zonulin, and IgA in fecal samples [ Time Frame: Baseline to 12 weeks ]
    The concentration of calprotectin, zonulin, and IgA in fecal samples will be determined by enzyme-linked immunosorbent assay (ELISA) as per kit providers' instructions before and after chronic exposure to study foods.

  6. Describe functional metagenomics alterations in gut microbiome [ Time Frame: Baseline to 12 weeks ]
    Fecal samples will be collected with standard collection kits and stored at -80°C until analysis. Metagenomic and transcriptomic analyses will be performed


Secondary Outcome Measures :
  1. Characterize metabolite profiles [ Time Frame: Baseline to 12 weeks ]
    Polyphenolic metabolites (phenolic acids and derivatives components) will be identified and quantified in urine and plasma.Metabolites in samples will be identified and quantified using an Agilent 6550 iFunnel UHPLC-QTOF-MS and 6460 UHPLC-QQQ-MS, respectively.

  2. Characterize bile acid metabolite pool [ Time Frame: Baseline to 12 weeks ]
    Bile acids in plasma and fecal samples will be determined using UHPLC-QQQ-MS.


Other Outcome Measures:
  1. Cognitive assessment: learning [ Time Frame: Baseline to 12 weeks ]
    California Verbal Learning Test® | Second Edition (CVLT®-II) will be measured in baseline and 12 weeks

  2. Cognitive assessment: basic attention, and working memory. [ Time Frame: Baseline to 12 weeks ]
    A subtest of the WAIS-IV, Digit Span will be measured in baseline and 12 weeks

  3. Cognitive assessment: verbal phonemic (letter) and semantic (category) fluency [ Time Frame: Baseline to 12 weeks ]
    Verbal Fluency: FAS + Animals test will be measured in baseline and 12 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women, age 18 or older
  • BMI ≥ 25 kg/m2
  • Fasting blood glucose concentration between 100 mg/dL and 125 mg/dL at the screening visit
  • Nonsmokers (Past smokers can be allowed if they have abstinence for a minimum of 2 years)
  • Judged to be in good health on the basis of the medical history ie., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • Not taking any medications that would interfere with outcomes of the study, i.e. lipid-lowering medications, anti-inflammatory drugs, dietary supplements, etc.
  • Able to provide informed consent
  • Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, records of food diary and GI-tract questionnaire, sample collection procedures and study visit schedule)
  • Able to maintain the usual physical activity pattern
  • Able to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during the study visit

Exclusion Criteria:

  • Men and women who smoke
  • Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
  • Men and women who have blood pressure >160 mmHg (systolic)/100 mmHg (diastolic) at the screening visit
  • Men and women who have fasting blood glucose concentration <100 or >125 mg/dL at the screening visit
  • Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
  • Men and women with cancer other than non-melanoma skin cancer in the previous 5 years
  • Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaints (e.g. irritable bowel syndrome)
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study
  • Women who are lactating
  • Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid-lowering medication, blood pressure-lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
  • Men and women who have participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
  • Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI.
  • Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator.
  • Taking the fiber supplements and/or on high fiber diets
  • Has used antibiotics within the previous 2 months
  • Had gastrointestinal barium opaque meal within 3 months
  • Has used prebiotics, probiotics, or drugs active on gastrointestinal motility, or a laxative of any class within 1 month
  • History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
  • Substance (alcohol or drug) abuse within the last 2 years
  • Excessive coffee and tea consumers (> 4 cups/d)
  • Donated blood within last 3 months
  • Men and women who do excessive exercise regularly or are an athlete
  • Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
  • Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
  • Unusual working hours i.e., working overnight (e.g. 3rd shift)

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): NCT04267705


Contacts
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Contact: Indika Edirisinghe, Ph.D 312-567-5300 freemanstudies@iit.edu
Contact: Di Xiao, PhD-c 312-567-5317 dxiao6@iit.edu

Locations
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United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Clinical Nutrition Research Center, Illinois Institute of Technology
USDA Beltsville Human Nutrition Research Center
Investigators
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Principal Investigator: Indika Edirisinghe, Ph.D Illinois Insititute of Technology

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Responsible Party: Clinical Nutrition Research Center, Illinois Institute of Technology
ClinicalTrials.gov Identifier: NCT04267705    
Other Study ID Numbers: 2019-070
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinical Nutrition Research Center, Illinois Institute of Technology:
Pulses
gut microbiota
Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Inflammation
Overweight
Pathologic Processes
Body Weight
Signs and Symptoms
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs