Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04823806
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-10
First Post:
2021-03-24
Brief Title:
An Exploratory Clinical Study on Autophagy and Multi-level Molecular Profiling During Spermidine Supplementation
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Autophagy Characterization and Multi-level Molecular Profiling of Spermidine Supplementation a Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
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:
None
Brief Summary:
Recently the autophagy inducing caloric restriction mimic spermidine became available Autophagy is essential for energy and cellular homeostasis through protein catabolism and dysregulation results in compromised proteostasis stress-coping behavior and in excessive secretion of signaling molecules and inflammatory cytokines Antidepressants for example effect autophagy dependent pathways to exert their beneficial effects It can therefore be hypothesized that autophagy induction through spermidine supplementation also shows beneficial clinical effect particularly in the field of psychiatric conditions It would be safe low cost and easy to implement in relay to psychotropic medication in the treatment of psychiatric patientsTherefore the aim of the project is to analyze clinical effects of spermidine supplementation in correlation to the underlying multi-level molecular profiling
Detailed Description:
Recently the autophagy inducing caloric restriction mimic spermidine-rich wheat germ extract spermidineLIFE from here onwards spermidine was approved by the European Food Safety Authority EFSA and became commercially available for use Spermidine is safe well tolerated and as caloric restriction mimetic an easy alternative if fasting is too challenging eg for psychiatric patients Research on spermidine in animal models is limited but a study with mice overexpressing spermidinespermine N1-acetyltransferase SSAT an enzyme of spermidine catabolism suggests that these mice may be more prone to stress An association between spermidine supplementation and improved memory performance as well as reduced mortality has been shown in an epidemiological correlation So far laboratory and molecular assessments are missing It is therefore of great interest to perform broad multidisciplinary studies of behavioral changes with plasma spermidine levels the quantification of autophagic flux and protein acetylation levels as well as molecular signaling in a longitudinal fashion to establish an epidemiological triangulation between spermidine autophagy and mental health
This study is a monocentric randomized double-blind placebo-controlled trial in which a 3-week spermidine-based nutritional supplementation 6 mgd target intervention will be compared to 3-weeks of placebo administration control intervention Recruitment of 40 healthy individuals and 40 individuals with diagnosed depressive disorder is planned who will be allocated to one of the two study arms n 20 per intervention At different time points baseline intervention day 7 14 and 21 as well as one week follow up after the last intervention day serval psychometrical questionnaires will be gathered and blood will be collected Sleep quality will be additionally assessed by actigraphy At selected days blood will be collected Following autophagy activity will be assessed by Western Blot analysis and mass spectrometry based proteomics phosphoproteomics metabolomics and lipidomics will be performed Bioinformatic analysis statistical evaluation quality control and in silico pathway analyses will then specifically identify factors and cascades of relevance Furthermore it is of great interest whether epigenetic changes take place during spermidine supplementation and whether these are stable throughout the follow up analysis
The aim of the project is to analyze clinical effects of spermidine supplementation in correlation to the underlying multi-level molecular profiling Longitudinal multi-omic profiling including proteome metabolome lipidome and epigenetic changes will reveal time-series analysis of thousands of molecular changes and an orchestrated composition of autophagy depended signaling The resulting findings will advance the role of autophagy in the development of psychiatric disorders investigate alternative treatment options on a molecular level and finally contribute to a better clinical outcome
This study is a monocentric randomized double-blind placebo-controlled trial in which a 3-week spermidine-based nutritional supplementation 6 mgd target intervention will be compared to 3-weeks of placebo administration control intervention Recruitment of 40 healthy individuals and 40 individuals with diagnosed depressive disorder is planned who will be allocated to one of the two study arms n 20 per intervention At different time points baseline intervention day 7 14 and 21 as well as one week follow up after the last intervention day serval psychometrical questionnaires will be gathered and blood will be collected Sleep quality will be additionally assessed by actigraphy At selected days blood will be collected Following autophagy activity will be assessed by Western Blot analysis and mass spectrometry based proteomics phosphoproteomics metabolomics and lipidomics will be performed Bioinformatic analysis statistical evaluation quality control and in silico pathway analyses will then specifically identify factors and cascades of relevance Furthermore it is of great interest whether epigenetic changes take place during spermidine supplementation and whether these are stable throughout the follow up analysis
The aim of the project is to analyze clinical effects of spermidine supplementation in correlation to the underlying multi-level molecular profiling Longitudinal multi-omic profiling including proteome metabolome lipidome and epigenetic changes will reveal time-series analysis of thousands of molecular changes and an orchestrated composition of autophagy depended signaling The resulting findings will advance the role of autophagy in the development of psychiatric disorders investigate alternative treatment options on a molecular level and finally contribute to a better clinical outcome
Study Oversight
Has Oversight DMC:
None
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?:
None