Insulin SensitivityPSNCT04267705
Pulses Consumption and Its Role in Managing Systemic Inflammation, Insulin Sensitivity and Gut Microbiome in Human
A study testing Black bean and Chickpea in people with Insulin Sensitivity and Overweight or Obesity, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Overweight or Obesity, Inflammatory Response
- What is being tested?
- Black bean and Chickpea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Understanding the Pulse-Gut Relationship and it's Role in Modifying Systemic Inflammation and Insulin Sensitivity in Humans
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.
Read the 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:
- Control group, (n=22): This group will receive a cup of white rice 7 days/week over a 12-week period.
- Black bean group, (n=22): This group will receive a cup of black bean 7 days/week over a 12-week period.
- 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.
- Being tested
- Control, Black bean, Chickpea
- Keywords
- Pulses, gut microbiota
- Medical subject headings
- Insulin Resistance, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
This group will receive a cup of rice 7 days/week over a 12-week period
Black beanOther
This group will receive a cup of black bean7 days/week over a 12-week period
ChickpeaOther
This group will receive a cup of chick pea 7 days/week over a 12-week period
| Study group | Role | What they receive |
|---|---|---|
| Black bean | Active comparator | A cup of black bean 7 days/week over a 12-week period Receives: Other: Black bean |
| Chickpea | Active comparator | A cup of chickpea 7 days/week over a 12-week period Receives: Other: Chickpea |
| Control | Placebo comparator | A cup of white rice 7 days/week over a 12-week period Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB
Investigate Nrf2/ NF-κB activation in PBMC
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Characterize metabolite profiles
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.
Measured: Baseline to 12 weeks
Characterize bile acid metabolite pool
Bile acids in plasma and fecal samples will be determined using UHPLC-QQQ-MS.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start24 Feb 2020
- Primary completion30 May 2023
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a randomized, 3-arm, parallel, placebo-controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Sponsor
- Investigators
- Indika Edirisinghe, Ph.D, Principal investigator, Illinois Insititute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267705
- Sponsor's protocol ID
- 2019-070
- Acronym
- PS
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2020
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Pulse-Gut Relationship and it's Role in Modifying Systemic Inflammation and Insulin Sensitivity in Humans
- ClinicalTrials.gov ID
- NCT04267705
- Acronym / sponsor ID
- PS / 2019-070
- Keywords
- Pulses, gut microbiota
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Control group, (n=22): This group will receive a cup of white rice 7 days/week over a 12-week period.
- Black bean group, (n=22): This group will receive a cup of black bean 7 days/week over a 12-week period.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The proposed study is a randomized, 3-arm, parallel, placebo-controlled design
| Arm | Type | Receives |
|---|---|---|
| Black bean | Active comparator | Other: Black beanA cup of black bean 7 days/week over a 12-week period |
| Chickpea | Active comparator | Other: ChickpeaA cup of chickpea 7 days/week over a 12-week period |
| Control | Placebo comparator | Other: ControlA cup of white rice 7 days/week over a 12-week period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThis group will receive a cup of rice 7 days/week over a 12-week period | Other | Control |
| Black beanThis group will receive a cup of black bean7 days/week over a 12-week period | Other | Black bean |
| ChickpeaThis group will receive a cup of chick pea 7 days/week over a 12-week period | Other | Chickpea |
Primary outcome
Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB
Time frame: Baseline to 12 weeks
Investigate Nrf2/ NF-κB activation in PBMC
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
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.
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
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.
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
2 secondary outcomes
Characterize metabolite profiles
Time frame: Baseline to 12 weeks
Characterize bile acid metabolite pool
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indika Edirisinghe, Ph.D principal investigator
Illinois Insititute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black bean and Chickpea in people with Insulin Sensitivity and Overweight or Obesity, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB (time frame: Baseline to 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.