The aim of this study was to evaluate the effect of psychobiotic supplementation containing Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071 and Bifidobacterium longum R0175 strains on mental health, quality of life, anthropometric measurements and some biochemical parameters in obese women. In the randomized double-blind placebo-controlled study, 28 obese female participants (14 psychobiotic, 14 placebo) will be given psychobiotic supplement/placebo together with a weight loss diet once a day every day for 4 weeks. Before and after the intervention, anthropometric measurements, blood samples and 24-hour retrospective 3-day food consumption records of the participants will be taken. In addition, the Depression Anxiety Stress Scale (DASS-21) will be administered to measure mental health, the SF-36 Quality of Life Scale to determine quality of life, and the International Physical Activity Questionnaire (IPAQ) to determine physical activity levels. Psychobiotics, which have entered our lives in recent years, have many beneficial effects on mental health through gut microbiota. However, while the effects of psychobiotics on mental health have been studied, their effects on obesity have not been investigated much. This study is unique in that it is the first study to investigate the effect of psychobiotic use on mental health in obese individuals. However, obesity is known to be an inflammatory disease and there is no study in the literature that includes the systemic immune inflammation index (SII) as a biomarker. SII is effective in evaluating the inflammatory and immune response in the body and determining prognosis; it adds value to clinical practice with early diagnosis of diseases, treatment follow-up and a wide range of uses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Lactobacillus helveticus R0052 Bifidobacterium bifidum R0071 Bifidobacterium longum R0175
Maltodextrin
Istanbul Medipol University
Istanbul, Turkey (Türkiye)
Changes in Body Weight (kg) from Baseline to Week 4
Time frame: Baseline and Week 4
Changes in Body Mass Index (BMI) from Baseline to Week 4
Body Mass Index (BMI) will be calculated as weight (kg) / height (m²). Higher BMI values indicate higher body fatness.
Time frame: Baseline and Week 4
Changes in mental health status with DASS-21 from Baseline to Week 4
Depression, Anxiety, and Stress Scale-21 (DASS-21). Scores range from 0 to 63 for each subscale, with higher scores indicating worse mental health status.
Time frame: Baseline and Week 4
Changes in Quality of Life with SF-36 from Baseline to Week 4
Short Form-36 Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline and Week 4
Changes in C-Reactive Protein (CRP) Levels from Baseline to Week 4
C-reactive protein (CRP) measured in mg/L. Higher values indicate greater inflammation.
Time frame: Baseline and Week 4
Changes in Interleukin-6 (IL-6) Levels from Baseline to Week 4
Interleukin-6 (IL-6) measured in pg/mL. Higher values indicate greater inflammation.
Time frame: Baseline and Week 4
Changes in Systemic Immune-Inflammation Index (SII) from Baseline to Week 4
SII calculated as (Platelets × Neutrophils) / Lymphocytes. Higher scores indicate higher systemic inflammation.
Time frame: Baseline and Week 4
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