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Active, not recruiting Not applicable

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

NCT04267705 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2020-02-24
Last updated
2026-08-28

Condition(s) studied

Insulin SensitivityOverweight or ObesityInflammatory Response

Investigational drug(s) / intervention(s)

ControlBlack beanChickpea

Control: This group will receive a cup of rice 7 days/week over a 12-week period

Black bean: This group will receive a cup of black bean7 days/week over a 12-week period

Chickpea: This group will receive a cup of chick pea 7 days/week over a 12-week period

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB — Baseline to 12 weeks
    Investigate Nrf2/ NF-κB activation in PBMC
  • Changes in plasma systemic and gut inflammatory markers — Baseline to 12 weeks
    Collected plasma samples will be used to measure selected inflammatory markers (IL6, hs-CRP and TNF-α) using ELISA methods
  • Determination of GLP-2 in plasma — 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.
  • Determination of TLR-2/4 gene expression in Human PBMC — Baseline to 12 weeks
    Determination of TLR-2/4 gene expression in Human PBMC using RT-PCR method
  • Gut inflammatory markers: Calprotectin, zonulin, and IgA in fecal samples — 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.
  • Describe functional metagenomics alterations in gut microbiome — 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

Trial sites (1)

FacilityCityRegionStatus
Clinical Nutrition Research Center Chicago Illinois
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04267705 on ClinicalTrials.gov ↗ ← All trials in the USA