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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT05327868
Eligibility Criteria:
Inclusion Criteria:
* Men or Women
* Age 50-79 years (only postmenopausal women \> 2 years)
* Body mass index (20-25 kg/m2; and 30-40 kg/m2)\*
Exclusion Criteria:
* Diagnosed with, active, or history of liver cirrhosis, chronic or persisting hepatitis
* Diagnosed with, active, or history of cancer
* History of gastrointestinal disease or surgical procedure for weight loss.
* Diagnosed with immune diseases, type 2 diabetes, pancreatitis, or infectious diseases
* Any surgery in the past 6 months
* Currently using or have used antibiotics continuously \> 3 days in the past 3 months
* Regular use of medications for that affect the gastrointestinal tract, cholecystitis, urinary tract infection, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS
* Known allergy or intolerance to any ingredients in the dietary intervention program
* Alcohol or illicit drug abuse
* Current Smoker or have quit smoking in the past 3 months
* Recent colonoscopy (within the previous two months)
* Inability to follow any of the experimental diets (including low or high fat diet) or to perform the collections required for this study
* Participants will also be excluded if they have extreme dietary habits, extreme levels of physical or athletic activity, or by changes in body weight \>5 lbs. during the last 6 months
* Uncontrolled hypertension or uncontrolled hyperlipidemia in abnormal ranges.
* Participation in another clinical research trial that may interfere with the results of this study.
* As needed, BMI (kg/m2) will be adjusted accordingly for Asian lean and obese definitions
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
79 Years
Study:
NCT05327868
Study Brief:
Protocol Section:
NCT05327868