ObesityNCT06861049
Psychobiotics and Mental Health in Obese Women on a Weight-Loss Diet
A study testing Psychobiotic Supplement in people with Obesity and Mental Health, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Mental Health, Probiotic
- What is being tested?
- Psychobiotic Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2025to 3 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged ≥ 18-65 years
- BMI ≥30 kg/m2
- Willingness to volunteer
- Able to give written consent
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity, Mental Health, Probiotic
- Being tested
- Psychobiotic Supplement, Placebo Supplement
- Medical subject headings
- Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychobiotic SupplementDietary supplement
Lactobacillus helveticus R0052 Bifidobacterium bifidum R0071 Bifidobacterium longum R0175
Placebo SupplementDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Psychobiotic Group | Experimental | Participants will receive a psychobiotic supplement along with a weight-loss diet. Receives: Dietary Supplement: Psychobiotic Supplement |
| Placebo Group | Placebo comparator | Participants will receive a placebo supplement along with a weight-loss diet. Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Weight (kg) from Baseline to Week 4
Measured: 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.
Measured: Baseline and Week 4
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start13 Feb 2025
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Melda Karaağaç, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861049
- Sponsor's protocol ID
- IMU-BES-RMK-01
- Status last verified
- Aug 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychobiotic Use on Mental Health, Quality of Life, Anthropometric and Biochemical Outcomes in Obese Women on a Weight-loss Diet
- ClinicalTrials.gov ID
- NCT06861049
- Acronym / sponsor ID
- IMU-BES-RMK-01
- Conditions
- Obesity, Mental Health, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychobiotic Group | Experimental | Dietary Supplement: Psychobiotic SupplementParticipants will receive a psychobiotic supplement along with a weight-loss diet. |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo SupplementParticipants will receive a placebo supplement along with a weight-loss diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults aged ≥ 18-65 years
- BMI ≥30 kg/m2
- Willingness to volunteer
- Able to give written consent
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychobiotic SupplementLactobacillus helveticus R0052 Bifidobacterium bifidum R0071 Bifidobacterium longum R0175 | Dietary supplement | Psychobiotic Group |
| Placebo SupplementMaltodextrin | Dietary supplement | Placebo Group |
Primary outcome
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
Time frame: Baseline and Week 4
Body Mass Index (BMI) will be calculated as weight (kg) / height (m²). Higher BMI values indicate higher body fatness.
5 secondary outcomes
Changes in mental health status with DASS-21 from Baseline to Week 4
Time frame: Baseline and Week 4
Changes in Quality of Life with SF-36 from Baseline to Week 4
Time frame: Baseline and Week 4
Changes in C-Reactive Protein (CRP) Levels from Baseline to Week 4
Time frame: Baseline and Week 4
Changes in Interleukin-6 (IL-6) Levels from Baseline to Week 4
Time frame: Baseline and Week 4
Changes in Systemic Immune-Inflammation Index (SII) from Baseline to Week 4
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychobiotic Supplement in people with Obesity and Mental Health, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Body Weight (kg) from Baseline to Week 4 (time frame: Baseline and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.