- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05276479
Dietary Plant Hormone and Mental Health
August 18, 2025 updated by: University of Bern
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
538
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bern, Switzerland, 3000
- University Hospital of Psychiatry, University of Bern
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy subjects
Description
Inclusion Criteria:
- Age 18 to 30
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy subjects
Healthy subjects aged 18-30 years
|
Assessment of regular feeding behavior and mental health
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline
|
|
General Psychopathology
Time Frame: At baseline
|
Brief Symptom Checklist (BSCL former BSI), including various subscales such as depression, anxiety
|
At baseline
|
|
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.
|
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress and Coping
Time Frame: At baseline
|
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.
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leila M Soravia, Prof. Dr., University Hospital of Psychiatry, University of Bern
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
November 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
March 2, 2022
First Submitted That Met QC Criteria
March 2, 2022
First Posted (Actual)
March 11, 2022
Study Record Updates
Last Update Posted (Actual)
August 24, 2025
Last Update Submitted That Met QC Criteria
August 18, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABA2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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