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:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT03231618
Eligibility Criteria:
Inclusion Criteria:
* Male subjects, aged 18-45 years
* 20 normal weight (18.5≤ BMI\<24) and 20 overweight / obesity (BMI ≥24)
* No participating in other clinical studies within previous 3 months
Exclusion Criteria:
* Alcoholic (100 grams of alcohol per drink, or 250 grams of rice wine, or 5 bottles of beer, ≥ 5 times a week)
* Diabetic patients or the use of insulin, hypoglycemic agents
* Taking antihypertensive drugs (diuretics, β blockers drugs, etc.) or lipid lowering drugs (class "bite", bile acids, statins, etc.) at present or once (within 6 months before the experiment)
* Having serious cardiovascular and cerebrovascular diseases at present or before, may interfere with the normal operation of the experiment (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, receiving interventional therapy, etc.)
* Having severe gastrointestinal diseases that affect food digestion and absorption, such as severe diarrhea in the past 3 months (3 or more times per day and lasting for 3 days or more); severe constipation in the past 3 months (2 times a week or less, accompanied by difficulties in defecation)
* Having received drug treatment over the past 3 months due to the following diseases: cholecystitis, gastrointestinal ulcers; urinary tract infection, acute pyelonephritis, cystitis; having undergone any surgery, in addition to appendicitis, hernia surgery; having taken or taking drugs that will affect the digestion and absorption system
* Attempting to change weight recently(weight loss, being on a diet, or weight gain)
* Subjects with severe liver and kidney disease (alanine aminotransferase, serum creatinine exceeded 1.5 times of the normal range set by the hospital)
* Subjects with severe thyroid disease (hyperthyroidism or hypothyroidism) or pituitary disease
* Subjects with anemia (hemoglobin \<120 g per liter)
* Subjects with cancer or who have received radiotherapy or chemotherapy within five years
* Having any mental illness; epilepsy patients or receiving antiepileptic treatment; using antidepressants
* Suffering from AIDS, hepatitis A, hepatitis B or other infectious diseases
* Physical disability
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03231618
Study Brief:
Protocol Section:
NCT03231618