Pulses Consumption and Its Role in Managing Systemic Inflammation, Insulin Sensitivity and Gut Microbiome in Human (PS)
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|ClinicalTrials.gov Identifier: NCT04267705|
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The proposed study is a randomized, 3-arm, parallel, placebo-controlled design|
|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|
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
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
This group will receive a cup of rice 7 days/week over a 12-week period
- 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
- 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.
- 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.
- 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
- 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
- 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
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
|Contact: Indika Edirisinghe, Ph.Dfirstname.lastname@example.org|
|Contact: Di Xiao, PhDemail@example.com|
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|Principal Investigator:||Indika Edirisinghe, Ph.D||Illinois Insititute of Technology|