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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Insulin Sensitivity, Overweight or Obesity, Inflammatory Response

In brief

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.

Key facts

Study ID: NCT04267705
Run by: Clinical Nutrition Research Center, Illinois Institute of Technology
People needed: 103
Starts: 2020-02-24
Expected to finish: 2026-01-30
Last updated by the study team: 2025-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
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)

Where it is running

Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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