Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT04267705
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.
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.
Study:
NCT04267705
Study Brief:
Protocol Section:
NCT04267705