Dietary BehaviorNCT05276479
Dietary Plant Hormone and Mental Health
An observational study of Dietary Behavior and Stress, run by University of Bern at 1 site in Switzerland.
Trial summary
The aim of this cross-sectional online study is to investigate the association between regular feeding behavior and stress, sleep as well as anxiety and depressive symptoms in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Behavior, Stress, Sleep
- What is being tested?
- Anonymous online survey on dietary habits and mental health
- How many people
- 538 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2022to 1 Dec 2022
- Phase
- Observational
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects
Who may be able to join
- Age 18 to 30
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Psychiatry, University of Bern
Bern, 3000
About this study
Official title: Association Between Dietary Plant Hormone Intake and Mental Health
The aim of this cross-sectional online study is to investigate the association between regular feeding behavior and stress, sleep as well as anxiety and depressive symptoms in healthy subjects.
Read the detailed description
The gut-microbiota-brain (GMB) axis has a multidirectional communication between the intestine, the microbiota, and the central nervous system (CNS). Over the past decade, there has been extensive research showing that the GMB axis has a profound influence not only on neurological disorders but also on neural development, activation of the neuroendocrine axis and neurotransmission, as well as modulation of complex human behaviors. Thus, the GBM-axis is involved in the regulation of stress, emotions, behaviour, and higher cognitive functions. As the GMB plays an essential role in human psychological functioning and mental health, the dietary manipulation of the microbiome may have direct effects on mental well-being, sleep, anxiety and depressive symptoms.
- Conditions
- Dietary Behavior, Stress, Sleep, Depression, Anxiety
- Being tested
- Anonymous online survey on dietary habits and mental health
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anonymous online survey on dietary habits and mental healthOther
Assessment of regular feeding behavior and mental health
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects aged 18-30 years Receives: Other: Anonymous online survey on dietary habits and mental health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental well-being and quality of life
Subjective life-quality will be measured with the short version of the World Health Organization Quality of Life questionnaire (WHOQOL-BREF,). The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". For the present study only the three subscales (physical and psychological health, and social relationships) will be assessed.
Measured: At baseline
General Psychopathology
Brief Symptom Checklist (BSCL former BSI), including various subscales such as depression, anxiety
Measured: At baseline
Sleep
Sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI). Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Measured: At baseline
Secondary outcomes (1)
Stress and Coping
Stress will be assessed with the Stress and Coping Inventory (SCI).The SCI is used to determine the current stress load and stress symptoms and to illustrate how to deal with stress using five coping strategies. It comprises 10 scales with 54 items: (A) Current stress load (1) Stress due to uncertainty, (2) Stress due to overload, (3) Stress due to loss and actual negative events, (4) Total stress: Total stress due to insecurity, threat, overload or loss in important areas of life, (5) Physical and psychological stress symptoms; (B) Stress coping (Coping) (1) Positive thinking, (2) Active stress coping, (3) Social support, (4) Keeping faith, (5) Increased alcohol and cigarette consumption.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 May 2022
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary BehaviorStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila M Soravia, Prof. Dr., Principal investigator, University Hospital of Psychiatry, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276479
- Sponsor's protocol ID
- ABA2022
- Status last verified
- Aug 2025
- First submitted
- 2 Mar 2022
- Last updated
- 24 Aug 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Dietary Plant Hormone Intake and Mental Health
- ClinicalTrials.gov ID
- NCT05276479
- Acronym / sponsor ID
- ABA2022
- Conditions
- Dietary Behavior, Stress, Sleep, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 Mar 2022 (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 cross-sectional online study is to investigate the association between regular feeding behavior and stress, sleep as well as anxiety and depressive symptoms in healthy subjects.
Detailed description
The gut-microbiota-brain (GMB) axis has a multidirectional communication between the intestine, the microbiota, and the central nervous system (CNS). Over the past decade, there has been extensive research showing that the GMB axis has a profound influence not only on neurological disorders but also on neural development, activation of the neuroendocrine axis and neurotransmission, as well as modulation of complex human behaviors. Thus, the GBM-axis is involved in the regulation of stress, emotions, behaviour, and higher cognitive functions. As the GMB plays an essential role in human psychological functioning and mental health, the dietary manipulation of the microbiome may have direct effects on mental well-being, sleep, anxiety and depressive symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Anonymous online survey on dietary habits and mental healthHealthy subjects aged 18-30 years |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects
Key inclusion criteria (1 listed)
- Age 18 to 30
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Anonymous online survey on dietary habits and mental healthAssessment of regular feeding behavior and mental health | Other | Healthy subjects |
Primary outcome
Mental well-being and quality of life
Time frame: At baseline
Subjective life-quality will be measured with the short version of the World Health Organization Quality of Life questionnaire (WHOQOL-BREF,). The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". For the present study only the three subscales (physical and psychological health, and social relationships) will be assessed.
General Psychopathology
Time frame: At baseline
Brief Symptom Checklist (BSCL former BSI), including various subscales such as depression, anxiety
Sleep
Time frame: At baseline
Sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI). Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
1 secondary outcome
Stress and Coping
Time frame: At baseline
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 24 Aug 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.
Leila M Soravia, Prof. Dr. principal investigator
University Hospital of Psychiatry, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Behavior and Stress, run by University of Bern at 1 site in Switzerland.
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 1 inclusion and 1 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 24 Aug 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 Switzerland. 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. 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?
Mental well-being and quality of life (time frame: At baseline). The study lists 3 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 24 Aug 2025.