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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT04023604
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 21-69 years old;
* BMI 22.0-34.9 kg/m2;
* Fasting serum total cholesterol \<240 mg/dL, low-density lipoprotein cholesterol \<160 mg/dL, triglycerides \<400 mg/dL, and glucose \<110 mg/dL;
* Systolic/diastolic blood pressure \<140/90 mmHg;
* Body weight stable (± 4 kg in previous 3 mo);
* Medication use stable for 6 months prior and not using medications or supplements known to impact gut function;
* No use of topical, oral or parenteral antibiotic medications in previous 6 months.
* Non-smoking;
* Physical activity regimen stable for 3 months prior;
* Not drinking more than 2 alcoholic drinks per day;
* No history of gastrointestinal disorders, surgeries or cancers;
* Non-pregnant and not lactating
* No acute illness and non-diabetic;
* Willing and able to consume the prescribed diets that may include meat, dairy and gluten-containing foods and beverages.
Exclusion Criteria:
* Male or female, \< 20 or \>70 years old;
* BMI \< 21.9- \>35 kg/m2;
* Fasting serum total cholesterol \>240 mg/dL, low-density lipoprotein cholesterol \>160 mg/dL, triglycerides \>400 mg/dL, and glucose \>110 mg/dL;
* Systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg;
* Body weight stable for \< 3 months prior (±3 kg);
* Stable physical activity regimen \< 3 months prior;
* Medication use unstable for 6 months prior and using medications or supplements known to impact gut function;
* Smoking;
* Drinking more than 2 alcoholic drinks per day;
* Diabetic;
* A history of gastrointestinal disorders, GI surgeries or GI cancers;
* Pregnant or lactating
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
69 Years
Study:
NCT04023604
Study Brief:
Protocol Section:
NCT04023604