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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT04097106
Eligibility Criteria:
Inclusion Criteria:
* BMI 19-25 (lean) and BMI 30-35 (obese)
* Age 18-45 years old
* subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
* willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)
Exclusion Criteria:
* antibiotic consumption within 28 days of study initiation
* diabetes
* kidney disorders
* history of cardiac disease and medications for cardiac disease
* use of statins and antihypertensive drugs
* inflammatory bowel disease
* irritable bowel syndrome
* history of small intestinal bacterial overgrowth
* history of intestinal surgery, excluding hernia repair and appendectomy
* active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
* immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
* abnormal liver or kidney function as measured by routine serum chemistry testing
* severe anemia or significant white blood cell or platelet abnormalities
* no additional blood or blood product donations during study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04097106
Study Brief:
Protocol Section:
NCT04097106