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

NCT04267705 | Active Not Recruiting

• 1 other identifier: 2019-070
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity; Overweight or Obesity; Inflammatory Response

Keywords

Pulses; gut microbiota

Outcome Measures

Primary Outcomes (6)

• Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB

  Investigate Nrf2/ NF-κB activation in PBMC

  Baseline to 12 weeks

• Changes in plasma systemic and gut inflammatory markers

  Collected plasma samples will be used to measure selected inflammatory markers (IL6, hs-CRP and TNF-α) using ELISA methods

  Baseline to 12 weeks

• Determination of GLP-2 in plasma

  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.

  Baseline to 12 weeks

• Determination of TLR-2/4 gene expression in Human PBMC

  Determination of TLR-2/4 gene expression in Human PBMC using RT-PCR method

  Baseline to 12 weeks

• Gut inflammatory markers: Calprotectin, zonulin, and IgA in fecal samples

  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.

  Baseline to 12 weeks

• Describe functional metagenomics alterations in gut microbiome

  Fecal samples will be collected with standard collection kits and stored at -80°C until analysis. Metagenomic and transcriptomic analyses will be performed

  Baseline to 12 weeks

Secondary Outcomes (2)

• Characterize metabolite profiles

  Baseline to 12 weeks

• Characterize bile acid metabolite pool

  Baseline to 12 weeks

Other Outcomes (3)

• Cognitive assessment: learning

  Baseline to 12 weeks

• Cognitive assessment: basic attention, and working memory.

  Baseline to 12 weeks

• Cognitive assessment: verbal phonemic (letter) and semantic (category) fluency

  Baseline to 12 weeks

Study Arms (3)

Black bean

ACTIVE COMPARATOR

A cup of black bean 7 days/week over a 12-week period

Other: Black bean

Chickpea

ACTIVE COMPARATOR

A cup of chickpea 7 days/week over a 12-week period

Other: Chickpea

Control

PLACEBO COMPARATOR

A cup of white rice 7 days/week over a 12-week period

Other: Control

Interventions

Control OTHER

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

Control

Black bean OTHER

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

Black bean

Chickpea OTHER

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

Chickpea

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• USDA Beltsville Human Nutrition Research Center: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Overweight; Obesity

Interventions

cicerin protein, Cicer arietinum

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Indika Edirisinghe, Ph.D

  Illinois Insititute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The proposed study is a randomized, 3-arm, parallel, placebo-controlled design

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 13, 2020
• Study Start: February 24, 2020
• Primary Completion: May 30, 2023
• Study Completion: January 30, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)