Actively Recruiting
Effect of Probiotics "Psychobiotics" on Depression and Metabolic Syndrome in Saudi Arabia
Led by Roaa Ahmed Alkreadees · Updated on 2025-09-22
60
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Probiotics "Psychobiotics" on Depression and Metabolic Syndrome in Saudi Arabia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with major depressive disorder and on antidepressants for at least 4 weeks
- Have pre-metabolic syndrome (at least 2 metabolic syndrome components) or metabolic syndrome (at least 3 of the following: central obesity, high fasting glucose, high blood pressure, high triglycerides, low HDL cholesterol)
- May have other comorbid conditions such as anxiety
You will not qualify if you...
- Using other mood-improving supplements
- Used pre/pro/symbiotics or antibiotics within 3 weeks before intervention
- Have chronic cardiac, renal, or hepatic diseases
- Have gastrointestinal diseases like Crohn's disease or ulcerative colitis
- Have infectious diseases such as HIV/AIDS
- Have cancer or are undergoing chemotherapy
- Have food allergies like gluten or lactose intolerance
- Are pregnant or breastfeeding
- Changed antidepressant dose or receiving psychotherapy during the study
- Have thyroid disorders
- Following a weight loss diet during the study
- Are insulin-dependent diabetic patients
- Taking weight loss injections or medications within 3 weeks before or during the study
- Using plasma-lipid lowering drugs for less than 1 month before the study
- Have substance abuse issues including alcohol addiction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
King Saud University Medical City
Riyadh, Riyadh Region, Saudi Arabia
Actively Recruiting
Research Team
R
Roaa A Alkreadees
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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