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Search / Trial NCT06861049

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

Launched by MEDIPOL UNIVERSITY · Mar 5, 2025

Trial Information

Current as of August 20, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a special type of probiotics, called psychobiotics, may help improve mental health in obese women who are trying to lose weight. The researchers want to see if taking these psychobiotics, which are specific strains of good bacteria, can lead to better mood, quality of life, and even some physical health measurements, like weight and blood markers. The study will involve 28 women aged between 18 and 65 who have a body mass index (BMI) of 30 or higher, and who are willing to commit to a 4-week weight-loss diet while taking either the psychobiotic supplement or a placebo (a non-active treatment).

Participants in the trial can expect to take their assigned supplement daily for four weeks while following a diet. Before and after the study, researchers will check various health measures, including weight, blood tests, and mental health questionnaires to track any changes. It's important to note that some people won’t be eligible for the study, such as those who are pregnant, have certain medical conditions, or are currently taking antibiotics. This study is unique because it looks at how these specific probiotics might help with mental health in obese individuals, which hasn't been widely researched before.

Gender

FEMALE

Eligibility criteria

  • 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.

About Medipol University

Medipol University is a leading academic institution dedicated to advancing medical research and clinical innovation. With a strong emphasis on interdisciplinary collaboration, the university conducts rigorous clinical trials aimed at improving patient outcomes and enhancing healthcare practices. Leveraging state-of-the-art facilities and a team of experienced researchers and healthcare professionals, Medipol University is committed to contributing to the global medical community through ethical research and the development of novel therapeutic strategies. The institution fosters an environment of academic excellence and integrity, ensuring that all trials adhere to the highest standards of safety and efficacy.

Locations

Istanbul, , Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported