Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04772651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-14
First Post:
2021-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression
Sponsor:
Medical University of Graz
Organization:
Study Overview
Official Title:
Mediterranean Diet and the Microbiota Gut Brain Axis- Does Diet Interact With the Function of Vagal Nerve in Major Depression?
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MeDiVa
Brief Summary:
The purpose of this study is to assess the efficacy of a Mediterranean diet on the function of the vagal nerve in patients with depression.
Detailed Description:
After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Subjects meeting the inclusion criteria will be randomized in a group recieiving a Mediterranean diet (3 mediterranean meals a day) and dietary coaching (1 session per week for 4 weeks) or a group with conventional hospital food and psychoeducation on depression (1 session per week for 4 weeks).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: