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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT07220369
Eligibility Criteria:
Inclusion Criteria:
* Men and postmenopausal women
* Age \>50 to \<75 years
* BMI \>20 to \<35 kg/m2
* Normotensive with or without medication
* Normal gastrointestinal function with regular bowel movements at least once every other day
* Normal kidney and liver function
* Willingness to swallow the mini-pills
* Willingness to collect and return multiple stool samples
* Adequate refrigerator and freezer space to store study entrées
* Intent to remain in the greater Boston area during the intervention periods
Exclusion Criteria:
* Individuals self-reporting adhering to any type of vegetarian diet
* Lack of willingness to restrict fish intake to less than once per week during the dietary intervention phases
* Allergy/intolerance/religious reasons to avoid study foods or food ingredients, including known hypersensitivity to Blue 1 food coloring and wheat gluten.
* Regular use of prebiotics or probiotics within the past 3 months
* Regular use of laxatives or fiber supplements
* Chronic constipation
* Chronic use of antibiotics (except topical)
* Regular use of stomach acid lowering and weight loss medications such as GLP-1 agonists
* Use of dental prophylaxis
* Planned colonoscopy 2 months prior to or during the study period
* Gastroparesis
* Swallowing disorder, or inability or difficulty taking pills
* Malabsorptive and inflammatory bowel disease, diverticulosis, and history of diverticulitis, gastric/ esophageal/intestinal surgery, including lap banding or bariatric surgery.
* History of bowel obstruction, pancreas and liver disorders.
* Any form of active substance abuse or dependence (including drug or alcohol abuse). This information will be stored in REDCAP in a subsection that has no identifiers.
* Established major chronic diseases such as cardiovascular disease, diabetes, active cancer within the last 5 years, or any significant medical condition at the study MD's discretion
* A clinical condition that, in the judgment of the study MD or principal investigator, could potentially pose a health risk to the subject while involved in the study.
* Unwillingness to adhere to study protocol
* Intent to increase or decrease body weight during the study period
* No Social Security number (for payment and IRS forms).
* Individuals who directly report to any member of the research team.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT07220369
Study Brief:
Protocol Section:
NCT07220369