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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Saudi Arabia
King Saud University Medical City
RECRUITING
Riyadh
Contact Information
Primary
Roaa A Alkreadees
442203635@student.ksu.edu.sa
00966555527073
Time Frame
Start Date: 2025-03-02
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 60
Treatments
Experimental: Winclove's Ecologic® Barrier Probiotics
Patients in the interventional group will consume psychobiotics daily in addition to their antidepressant medication for 12 weeks. All patients will be instructed to take 1 sachet in the morning before breakfast, and 1 sachet at the end of the day before going to bed. The product is a multispecies probiotic formulation consisting of 9 selected probiotic strains by Winclove's Ecologic® Barrier, Amsterdam, The Netherlands. Each participant will receive 6 boxes of the probiotic supplement, each box contains 30 sachets of 3 grams (180 sachets in total). During the period of 12 weeks, each participant will consume 168 sachets. The probiotic supplement is a freeze-dried powder of probiotic mixture at a dose of 2,5 x 109 colony forming units (CFU) per gram. Since participants should consume 2 sachets/day, they will consume 6 grams in total which equals 1.5 × 10\^10 CFU.
Placebo_comparator: Control
Patients in the control group will consume similar sachets that are identical in physical appearance. The placebo is composed of the carrier of the probiotic product, that is maize starch and maltodextrins but contains no bacteria.
Related Therapeutic Areas
Sponsors
Leads: Roaa Ahmed Alkreadees

This content was sourced from clinicaltrials.gov