Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
NCT06765057

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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