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 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT06104800
Eligibility Criteria:
Inclusion Criteria:
Phase 1
* Signing of the informed consent form
* Both sexes
* Adults over 18 years of age
* BMI of 18.5 and under 40 kg/m2
Phase 2
* Both sexes
* Adults older than 18 years
* People with obesity (BMI of 30 to 40 kg/m2) and serum iron \< 50 micrograms/dL.
* Total cholesterol less than 240 mg/dL (with the diet plan 20% decrease).
Exclusion Criteria:
* Any type of diabetes.
* Patients with renal disease diagnosed by a physician.
* Patients with acquired diseases that secondarily produce obesity and diabetes.
* Patients who have suffered a cardiovascular event.
* Weight loss \> 3 kg in the last 3 months.
* Patients with catabolic diseases such as cancer and acquired immunodeficiency syndrome.
* Pregnancy.
* Treatment with any drug treatment:
1. Treatment with antihypertensive drugs (loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers).
2. Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetics.
3. Treatment with statins, fibrates or other drugs to control dyslipidemia.
4. Use of steroid drugs, chemotherapy, immunosuppressants or radiotherapy.
5. Anorectics or drugs that accelerate weight loss.
6. Any drug or medication that activates intestinal motility (cisapride, dimethicone, domperidone, metoclopramide, trimebutine).
7. Laxatives or antispasmodics 4 weeks prior to the study h) Antibiotic treatment 2 months prior to the study.
* Patients who have suffered a blood loss of more than 500 ml or recent gastrointestinal tract perforation.
* Patients with a smoking index greater than 21.
* Consumption of large amounts of alcohol (14 drinks for women or 21 drinks for men in a normal week).
* Consumption of any recreational psychoactive substance.
* Treatment with any medication that influences inflammation or iron metabolism (proton pump inhibitors, antacids, bisphosphonates, bile acid or calcium sequestrants).
* Patients who are vegetarians
* Allergy or intolerance to any food mentioned in the proposed pantry such as egg, dairy, fish, tuna, chicken, beans, lima beans and/or lentils.
* Unwillingness to consume any of the foods listed in the proposed pantry.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06104800
Study Brief:
Protocol Section:
NCT06104800