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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT04211766
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Normal-overweight (body mass index \[BMI\] of 18-30 kg/m\^2)
* Women will be postmenopausal, with no menstrual period in 12 months
* Non-smoking
* Consume fiber intakes of less than \< 20 g/d
* White blood cell count 3,000-11,000/mm\^3
* Platelet count 100,000-400,000 mm\^3
* Hematocrit 33-50% (women); 36-50% (men)
* Bilirubin 0.2-1.3 mg/dL
* Aspartate aminotransferase (AST) 0-35 U/L
* Alanine aminotransferase (ALT) 0-40 U/L
* Alkaline phosphatase 20-125 U/L
* Creatinine =\< 1.2 mg/dL
* Potassium 3.5-5.0 mmol/L
Exclusion Criteria:
* Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer \[HNPCC\], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer)
* Weight change greater than 4.5 kg within past year
* Oral or intravenous (IV) antibiotic use within the past 3 months
* Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
* Smoking or use of cannabis products
* Known allergy to fish
* Intention to relocate out of study area within next 4 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT04211766
Study Brief:
Protocol Section:
NCT04211766