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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT06765057
Eligibility Criteria:
Inclusion Criteria:
* Major Depression Disorder (MDD) patients on antidepressants for at least 4 weeks or more.
* MDD patients with pre-metabolic syndrome (at least 2 of the MetS components) and metabolic syndrome (at least 3 of the following components: central obesity with WC for men ≥ 94 centimeters while for women ≥ 80 centimeter, increased FPG ≥ 100 mg/dl, increased BP to ≥ 130 / ≥ 85 mmHg, increased TGs equal or above 150 mg / dl, increased HDL cholesterol for men to \< 40 mg / dl while for women \< 50 mg / dl) (IDF., 2006).
* MDD patients with other comorbid diseases such as anxiety.
Exclusion Criteria:
* Patients using any other supplements to improve mood.
* Patients using pre/pro/symbiotics supplement or antibiotics during the last 3 weeks before the intervention.
* Patients with chronic diseases (cardiac, renal, or hepatic diseases)
* Patients with gastro intestinal diseases (Crohn's disease, ulcerative colitis).
* Patients with infectious diseases (HIV/AIDS).
* Cancer patients or those undergoing chemotherapy.
* Patients with food allergies such as gluten intolerance or lactose intolerance.
* Pregnant and breastfeeding women.
* Patients with modified antidepressant dose during interventional period or receiving psychotherapy during the intervention.
* Patients with thyroid disorder.
* Patients following a diet to lose weight during the intervention.
* Diabetic patients who are insulin-dependent.
* patients receiving injections or medications to lose weight (Ozempic, Mounjaro …etc) either 3 weeks before or during the intervention.
* Patients using plasma-lipid lowering drug for less than 1 month before the intervention.
* Patients with substance abuse including alcohol addiction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06765057
Study Brief:
Protocol Section:
NCT06765057