Effect of Probiotics "Psychobiotics" on Depression and Metabolic Syndrome in Saudi Arabia

Launched by ROAA AHMED ALKREADEES · Jan 2, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a type of probiotic, known as "psychobiotics," can help improve symptoms of depression and assist with weight and metabolic health in adults who are both depressed and obese. The trial will involve participants who have been diagnosed with major depression and have certain health issues related to obesity, such as high blood pressure or high blood sugar levels. Researchers want to find out if taking these psychobiotics daily for three months can reduce depressive symptoms and improve measurements like weight and cholesterol levels compared to a placebo, which looks the same but doesn’t contain the active ingredient.

To be eligible, participants should be adults aged 18 to 65 who are currently taking antidepressants and meet specific health criteria, such as having a body mass index (BMI) of 30 or higher and showing signs of metabolic syndrome. During the study, participants will undergo health examinations and lab tests, take the supplement or a placebo daily, and have regular check-ins to monitor their progress and any side effects. This study is not yet recruiting participants, so there will be more updates in the future for those interested in joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Major Depression Disorder (MDD) patients on antidepressants for at least 4 weeks or more.
• • MDD patients with obesity (BMI ≥ 30 kg/m2) 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 (irritable bowel syndrome, 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 started receiving psychotherapy during the intervention.
• • Patients with thyroid disorder.
• • Patients with anemia.
• • Vegetarians.
• • Patients following a diet to lose weight during.
• • Diabetic patients.
• • Patients using plasma-lipid lowering drug.
• • Patients with substance abuse including alcohol addiction.