Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04726293
Eligibility Criteria:
Inclusion Criteria:
* Men or women, 20-60 years of age, inclusive with high sensitivity C-Reactive Protein (hs-CRP), a global marker of inflammation, \>1.0 and ≤10 ng/
* BMI ≥ 25 kg/m2
* Nonsmokers (Past smokers can be allowed if they have abstinence for 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 and study visit schedule)
* Able to maintain usual physical activity pattern
* Able to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during study visit
Exclusion Criteria:
* 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 screening visit
* Men and women who have fasting blood glucose concentration \>125 mg/dL at 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 previous 5 years
* Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (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
* Men and women who are 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.
* Men and women who have used antibiotics within the previous 2 months
* Men and women who had gastrointestinal barium opaque meal within 3 months
* Men and women who used prebiotics, probiotics, or drugs active on gastrointestinal motility, or a laxative of any class within 1 month
* Men and women with history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
* Men and women who had substance (alcohol or drug) abuse within the last 2 years
* Excessive coffee and tea consumers (\> 4 cups/d)
* Men and women who have donated blood within last 3 months
* Men and women who do excessive exercise regularly or are an athlete
* Men and women who have 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
* Men and women who have unusual working hours i.e., working overnight (e.g. 3rd shift)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT04726293
Study Brief:
Protocol Section:
NCT04726293