Dietary Plant Hormone and Mental Health

Stress Clinical Trial

Official title:

Association Between Dietary Plant Hormone Intake and Mental Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05276479
• Other study ID #: ABA2022
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2022
• Source: University of Bern
• Contact: Leila M Soravia, Prof. Dr.
• Phone: +41 31 930 91 11
• Email: leila.soravia[@]upd.unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Age 18 to 30

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Dietary Behavior
• Sleep
• Stress

Intervention

Other:
• Anonymous online survey on dietary habits and mental health
Assessment of regular feeding behavior and mental health

Locations

Country	Name	City	State
Switzerland	University Hospital of Psychiatry, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline
Primary	Depression	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.	At baseline
Primary	Sleep	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.	At baseline
Secondary	Anxiety	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".	At baseline
Secondary	Stress and Coping	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.	At baseline