Evaluation of the Specialized Clinic for Nutrition and Mental Health: A Pilot Study (NCT07050342) | Clinical Trial Compass
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Evaluation of the Specialized Clinic for Nutrition and Mental Health: A Pilot Study
Austria84 participantsStarted 2025-12-01
Plain-language summary
The goal of this observational pilot study is to learn how personalized nutrition-focused care can help people with mental and psychosomatic health problems. This study takes place in Europe's first outpatient clinic that focuses on how diet affects mental well-being.
The main questions the study aims to answer are:
Does care at this clinic help lower participants' stress levels over one year?
Do participants report better mental health, resilience, and quality of life during the study?
Are improvements in mental health linked to changes in diet and blood markers like inflammation?
Participants will:
Fill out online questionnaires every 3 months over one year. These ask about stress, physical symptoms, quality of life, diet, and satisfaction with care.
Give small blood samples during their regular clinic visits. These samples will be checked for common health markers such as inflammation.
This study will help researchers understand whether nutrition-focused care can support mental and physical health, and whether this approach should be tested in larger future studies.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion Criteria:
New patient at the outpatient clinic for Nutrition and Psychosomatics
Age between 18 and 65 years
Sufficient German language skills
Provided written informed consent
Able and willing to complete online questionnaires via email
Exclusion Criteria:
* Lack of consent or inability to provide informed consent
Diagnosed dementia (Mini-Mental State Exam \< 20)
Severe substance dependence (e.g., alcohol, benzodiazepines, opioids)
Serious physical, neurological, or motor impairments preventing questionnaire completion
No access to or ability to use email for online forms
Diagnosis of cancer, severe autoimmune disease, or immunosuppression
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in perceived stress levels measured by the Perceived Stress Scale (PSS-10)