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:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT04753359
Eligibility Criteria:
Inclusion Criteria:
* Men and women 45-75 years of age
* Self-identify as AA
* BMI 30-50 kg/m2
* Willingness to participate in all procedures including maintaining weight/current physical activity if randomized to Med-A/Control
* Willingness and ability to provide informed consent
* Willingness to be randomized
* Understands English
* Has access to a phone
* Plans to reside in Chicago for the next 8-10 months.
Exclusion Criteria:
* renal disease
* autoimmune disorders
* immunodeficiency
* malabsorptive disorders
* significant gastrointestinal and/or hepatic diseases
* severe ischemic heart disease
* severe pulmonary disease
* history of bariatric surgery
* alcohol abuse (\> 50 grams/day)
* illicit drug abuse (other than marijuana based on self-report)
* combustible tobacco use
* uncontrolled diabetes based on HbA1c\>9.0%
* eating disorder
* cancer treatment within the past 12 months
* history of CRC
* genetic predisposition to CRC (e.g., Lynch syndrome)
* weight \> 450 lbs. (weight limitation of the DXA scanner)
* currently adhering to a MedDiet based on a diet screener
* self-reported WL \> 3% in the past 12 months
* currently on a WL diet or actively involved in a formal WL program (e.g., Weight Watchers)
* food allergies that would interfere with adopting a MedDiet
* antibiotic use in the past 3 months
* night-shift work
* regular use (i.e., ≥ 3 times per week) of prebiotics/probiotics/synbiotics, dietary fiber supplements, or laxatives,
* Gait disorder
* currently pregnant
* active Covid-19 infection within 6 weeks of recruitment/data collection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT04753359
Study Brief:
Protocol Section:
NCT04753359