Recruiting

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

ClinicalTrials.gov IDNCT06765057

PhasePHASE2, PHASE3

Enrollment60

SponsorRoaa Ahmed Alkreadees

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression Anxiety Disorder

About this study

The goal of this clinical trial is to assess the effect of commercial multi-strains psychobiotics supplementation as an ad-on therapy on depressive symptoms and metabolic syndrome components (HDL-C, FPG, TGs, WC, BP) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The second goal is to explore the effect of commercial multi-strains psychobiotics supplementation on the anthropometric measurement (weight, body mass index (BMI)) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The main questions they aim to answer are: * Will commercial multi-strains psychobiotics supplementation help to ease depressive symptoms as an ad-on therapy in patients with pre-metabolic syndrome and metabolic syndrome? * Will commercial multi-strains psychobiotics supplementation improve anthropometric measurements and metabolic syndrome components (WC, FPG, BP, TGs, HDL-C) in depressed patients? Researchers will compare psychobiotics to a placebo (a look-alike substance that contains no drug) to see if psychobiotics work to improve depression and metabolic syndrome components. Participants will: * Be examined for depression, anxiety, and metabolic syndrome components (waist circumference, diabetes, blood pressure, triglycerides, and high-density lipoprotein). * Be asked to conduct laboratory tests to determine the inclusion and exclusion criteria. * Be given probiotics/ placebo to consume every day for 3 months (12 weeks). * Repeat the examination and laboratory tests to determine the results. * Be followed up weekly for adverse events and to insure their compliance with the study instructions. * Be followed up after 4 weeks as an end-visit and will conduct the examination and the laboratory blood tests.

Interventions

Dietary Supplement: Winclove's Ecologic® Barrier Probiotics — The investigational product is a multispecies probiotic formulation consisting of 9 selected probiotic strains: the following bacterial strains: Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58.
Dietary Supplement: Winclove's Ecologic® Barrier Probiotics Placebo — The placebo is composed of the carrier of the probiotic product that are identical in physical appearance, it includes maize starch and maltodextrins but contains no bacteria.

Primary outcomes

Psychological Assessment (depression1) (at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).)
Psychological Assessment (depression2) (at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).)
Psychological Assessment (Anxiety) (at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).)
Anthropometric Measurements (at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).)
Metabolic Syndrome Components (Waist circumference) (at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).)
Metabolic Syndrome Components (Medical Assessments/ Laboratory Tests) (at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).)
Metabolic Syndrome Components (Medical Assessments/ Blood Pressure) (at baseline, after the end of the 12th week of the intervention, and after 4 weeks post-intervention follow-up (end visit).)

Eligibility information

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.

Study locations

King Saud University Medical City, Riyadh, Riyadh Region Saudi Arabia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.