RecruitingPhase 2Phase 3NCT06765057

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

Effect of Probiotics "Psychobiotics" on Depression in Adults With Pre-Metabolic Syndrome and Metabolic Syndrome in Riyadh City


Sponsor

Roaa Ahmed Alkreadees

Enrollment

60 participants

Start Date

Mar 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether special gut-health probiotics — sometimes called psychobiotics — can help improve depression symptoms and metabolic health (like blood sugar, blood pressure, and cholesterol) in Saudi patients who have both depression and metabolic syndrome. **You may be eligible if...** - You have been diagnosed with Major Depression Disorder (MDD) and have been on antidepressants for at least 4 weeks - You also have metabolic syndrome or pre-metabolic syndrome — meaning you have at least 2-3 of these: high waist circumference, high blood sugar, high blood pressure, high triglycerides, or low good cholesterol (HDL) - You may have other conditions like anxiety alongside depression **You may NOT be eligible if...** - You are currently using other mood-boosting supplements - You have taken probiotics, prebiotics, or antibiotics in the past 3 weeks before the study - You have a condition that prevents you from taking oral supplements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTWinclove'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_SUPPLEMENTWinclove'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.


Locations(1)

King Saud University Medical City

Riyadh, Riyadh Region, Saudi Arabia

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NCT06765057


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