NCT06861049Completed
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
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 27 Feb 2025
- Start date
- 13 Feb 2025
- Primary completion date
- 3 Jul 2025
- Lead sponsor
- Medipol University
- Diseases
- Obesity
- NCT number
- NCT06861049
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 13 Feb 2025 to the primary completion date, 3 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Co-administration of probiotics. However, subjects will be eligible to participate after a four (4) week washout period.
- 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).
- Use of anti-inflammatory drugs
- Use of corticosteroids
Other illness
- 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).
- People who are allergic to milk, corn starch or soya.
Other
- Pregnant or planning to become pregnant within the next two (2) months.
- Positive pregnancy test in women of childbearing potential.
- Foreign nationality.
Who the study is looking for
- Healthy adults aged ≥ 18-65 years
- BMI ≥30 kg/m2
- Willingness to volunteer
- Able to give written consent
Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| İstanbul Medipol University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.