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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT06259435
Eligibility Criteria:
Inclusion Criteria:
1. Body mass index (BMI) ≥ 30kg/m2.
2. Mini-Mental State Examination (MMSE) \> 25
3. Geriatric Depression Scale-15 (GDS-15) \< 9
4. Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3.
Exclusion Criteria:
1. Diagnosis of Type 2 diabetes received more than five years ago
2. Diagnosis of type 1 diabetes
3. Evidence of clinically significant renal dysfunction or disease
4. History of malignancy during the past five years
5. Being treated with systemic steroids, olanzapine, or clozapine
6. Being treated with prescription medications for obesity
7. Being treated with thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin
8. Weight change \> 3 kg in the preceding three months
9. Any disease or condition that precludes testing of the study outcomes or makes it unsafe to consume the foods being tested in the study, or subjects are otherwise deemed to be unsuitable for participation in the study (determined by the investigative team)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT06259435
Study Brief:
Protocol Section:
NCT06259435