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.
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.
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).
Parallel
Winclove's Ecologic® Barrier Probiotics
Dietary supplementThe 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.
Winclove's Ecologic® Barrier Probiotics Placebo
Dietary supplementThe 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.
Psychological Assessment (depression1)
• Depression will be diagnosed clinically using the validated Arabic translated Patient Health Questionary 9 (PHQ-9) in Saudi population to assess the severity of depression as a self-report scale for patients in both groups. The minimum score is 0 while the maximum score is 27; the higher the score the more severe the depression is. Scores 0-4 means no depression; scores 5-9 means mild depression; scores 10-14 means moderate depression; score 15-19 means moderately severe, and 20-27 means severe depression.
Psychological Assessment (depression2)
• Hamilton Depression Rating Scale (HDRS) will be also used as a clinician-rated scale to evaluate the severity of depression symptoms. The most commonly used versions in are either a 17- or a 21-item scale, but this study uses the 21-item scale. The scoring of the severity of the depressive symptoms is based on 17 items. It is scored between 0 (not present) and 4 (severe) points using either a three-point or a five-point scale and summed up to obtain the total score. Scores 0-7 represent the absence or remission of depression; scores between 8-16 represent mild depression; scores between 17-23 represent moderate depression, and scores equal to 24 and above represent severe depression.
Psychological Assessment (Anxiety)
• Generalized Anxiety Disorder-7 (GAD-7) scale will be added to assess anxiety. Each of the 7 items is scored from 0 to 3, the GAD-7 scale score ranges from 0 to 21; the higher the score the more severe the anxiety is. Scores 0-4 means no anxiety; scores 5-9 means mild anxiety; scores 10-14 means moderate anxiety; score 15-21 means severe anxiety.
Anthropometric Measurements
Height and weight will be combined to calculate the body mass index (BMI). BMI will be measured through dividing individual's weight in kilograms by height in square meter. Lower than 18.5 means underweight; 18.5 to lower than or equal 25 means normal weight; 25.0 to lower than or equal 30 means overweight; 30.0 or above means obese (Centers for Disease Control and Prevention (CDC), 2020).
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Roaa Ahmed Alkreadees
Lead sponsor
King Saud Medical City
Sponsor institution
