Psychobiotics and Mental Health in Obese Women on a Weight-Loss Diet

The Effect of Psychobiotic Use on Mental Health, Quality of Life, Anthropometric and Biochemical Outcomes in Obese Women on a Weight-loss Diet

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 Overview

• Status: Completed
• Conditions: Obesity; Mental Health; Probiotic
• Intervention / Treatment: Dietary supplement: Psychobiotic Supplement; Dietary supplement: Placebo Supplement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults aged ≥ 18-65 years
• BMI ≥30 kg/m2
• Willingness to volunteer
• Able to give written consent

Exclusion Criteria:

• Co-administration of probiotics. However, subjects will be eligible to participate after a four (4) week washout period.
• Pregnant or planning to become pregnant within the next two (2) months.
• Positive pregnancy test in women of childbearing potential.
• Use of antibiotic medication (e.g. neomycin, rifaximin) within the last 1 month. If this is the case, the participant will be eligible to participate four (4) weeks after completion of antibiotic treatment (washout period).
• Individuals with physician-diagnosed psychiatric and neurological conditions.
• Individuals with irritable bowel syndrome or gastrointestinal disorders.
• People with immune disorders or possible immunodeficiency states (e.g. due to surgery).
• Use of anti-inflammatory drugs
• Use of corticosteroids
• People who are allergic to milk, corn starch or soya.
• Foreign nationality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychobiotic Group; Participants will receive a psychobiotic supplement along with a weight-loss diet.	Dietary supplement: Psychobiotic Supplement; Lactobacillus helveticus R0052 Bifidobacterium bifidum R0071 Bifidobacterium longum R0175
Placebo Comparator: Placebo Group; Participants will receive a placebo supplement along with a weight-loss diet.	Dietary supplement: Placebo Supplement; Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body Weight (kg) from Baseline to Week 4		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.	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline and Week 4

Collaborators and Investigators

• Sponsor: Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Actual): July 3, 2025
• Study Completion (Actual): July 3, 2025

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Personal Satisfaction; Obesity; Psychological Well-Being
• Other Study ID Numbers: IMU-BES-RMK-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No