## Protocol Section
### Identification Module
**NCT ID:** NCT05276479

**Brief Title:** Dietary Plant Hormone and Mental Health

**Official Title:** Association Between Dietary Plant Hormone Intake and Mental Health

#### Organization Study ID Info
**ID:** ABA2022
#### Organization
**Class:** OTHER
**Full Name:** University of Bern
### Status Module
#### Completion Date
**Date:** 2022-08-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2022-03-31

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-16

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-04-01

**Type:** ESTIMATED

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2022-03-11
**Type:** ACTUAL
**Study First Submit Date:** 2022-03-02
**Study First Submit QC Date:** 2022-03-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Bern

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Dietary Behavior

- Stress

- Sleep

- Depression, Anxiety

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Healthy subjects aged 18-30 years

**Intervention Names:**

- Other: Anonymous online survey on dietary habits and mental health

**Label:** Healthy subjects

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy subjects

**Description:** Assessment of regular feeding behavior and mental health

**Name:** Anonymous online survey on dietary habits and mental health

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Quality of life

**Time Frame:** At baseline

**Description:** Overall depressive symptoms assessed with the Beck Depression Inventory II (BDI-II; Beck, A., Steer, R., Brown, G., 1996). Each answer is scored on a scale value of 0-3. Measures of 0-9 indicates that a person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression.

**Measure:** Depression

**Time Frame:** At baseline

**Description:** Sleep quality is assessed with the Pittsburgh Sleep Quality Index (PSQI; Buysse, D., Reynolds, C., Monk, T., Berman, S., Kupfer, D.,1989). 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.

**Measure:** Sleep

**Time Frame:** At baseline

#### Secondary Outcomes

**Description:** Anxiety symptoms will be assessed with the validated German version of the Beck Anxiety Inventory (Beck and Steer 1988). A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe".

**Measure:** Anxiety

**Time Frame:** At baseline

**Description:** Stress will be assessed with the Stress and Coping Inventory (SCI; Satow, 2012).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.

**Measure:** Stress and Coping

**Time Frame:** At baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18 to 30

Exclusion Criteria:

* None

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** Healthy subjects

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** leila.soravia@upd.unibe.ch

**Name:** Leila M Soravia, Prof. Dr.

**Phone:** +41 31 930 91 11

**Role:** CONTACT

**Contact 2:**

**Email:** christelle.robert@ips.unibe.ch

**Name:** Christelle AM Robert, Prof. Dr.

**Phone:** +41 31 684 31 55

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bern

**Country:** Switzerland

**Facility:** University Hospital of Psychiatry, University of Bern

**Zip:** 3000

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital of Psychiatry, University of Bern

**Name:** Leila M Soravia, Prof. Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003863

- Term: Depression

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
