DepressionNCT04823806
An Exploratory Clinical Study on Autophagy and Multi-level Molecular Profiling During Spermidine Supplementation
A study of Depression and Healthy, run by University Hospital, Bonn at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Present written declaration of consent
- Healty or diagnosed with depression
- BMI between 17 and 40
Who cannot join
- Insufficient linguistic communication
- Pregnancy or lactation
- Gluten, histamine or wheat seedling intolerance
- Drug abuse or alcohol dependency
- Current spermidine substitution
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Bonn, Clinic for psychiatry and psychotherapy
Bonn, 53111
About this study
Official title: Autophagy Characterization and Multi-level Molecular Profiling of Spermidine Supplementation: a Clinical Study
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 patients.Therefore, the aim of the project is to analyze clinical effects of spermidine supplementation in correlation to the underlying, multi-level molecular profiling.
Read the 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, e.g. for psychiatric patients. Research on spermidine in animal models is limited, but a study with mice overexpressing spermidine/spermine 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 mg/d; 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.
- Conditions
- Depression, Healthy
- Being tested
- Spermidine (spermidineLIFE ®) OR Placebo
- Keywords
- Spermidine, Autophagy, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spermidine (spermidineLIFE ®) OR PlaceboDietary supplement
21 day of 6mg spermidine OR Placebo supplementation per day
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants and participants with depressive disorder: dietary spermidine supplementation | Experimental | Dietary Supplement: Polyamine 21 days of spermidine supplementation (3 sachets/day = 6mg spermidine/day) Receives: Dietary Supplement: Spermidine (spermidineLIFE ®) OR Placebo |
| Healthy participants and participants with depressive disorder: dietary placebo supplementation | Placebo comparator | Dietary Supplement: Placebo 21 days of Placebo supplementation (3 sachets/day) Receives: Dietary Supplement: Spermidine (spermidineLIFE ®) OR Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomics and autophagy processes
Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting.
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Secondary outcomes (25)
Epigenetic patterns
Evaluate epigenetic methylation patterns through blood based epigenome analysis
Measured: change from baseline to day 21 of supplementation to 7 day follow up
Proteome/phosphoproteome/ubiquitinome patterns
Change in protein levels and protein phosphorylation by untargeted mass spectrometry-based proteomics and phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells).
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Metabolic processes
Targeted and quantitative analysis by mass spectrometry of change in metabolites of Plasma.
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Lipid profiling
Targeted and quantitative analysis by mass spectrometry of change in plasma Lipids.
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Exosomal protein patterns
Evaluate exosomal protein content through mass spectrometry based analysis
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Glomerular filtration rate
Estimated glomerular filtration rate (eGFR) in milliliter per minute (mL/min)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Cystatin C
Cystatin C in Milligram per Liter (mg/L)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Liver Enzymes
Alanine transaminase (ALT) and aspartate transaminase (AST) (U/L)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
White blood cell differential
Absolute number (per Liter) and relative amounts of neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes (in %)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Saliva Cortisol Levels (dexamethasone suppression test)
Comparison of Saliva Cortisol Levels in nmol per Liter (nmol/L) after Dexamethason intake between spermidine and Placebo group
Measured: on day 19 and 20 of supplementation
Sleep Efficiency
Assessment of Sleep Efficiency (total time in bed/time asleep during night) by GenActive Aktigraphs
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Overall sleep Quality
Sleep diary to assess overall sleep quality assessed as ratio of the total time spent asleep (in hours) to the total amount of time spent in bed (in hours) per night
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Sleep Quality (PSQI)
Pittsburgh Sleep Quality Index (PSQI): self-report questionnaire to assess sleep quality over a 1-month time interval consisting of 19 individual items.
Measured: Change from baseline to day 7 day follow up visit
Mental well-being (WEMWBS)
Warwick-Edinburgh Mental Well-being Scale (WEMWBS): self-reported 14-item scale to assess Overall mental well-being
Measured: Change from baseline to day 14 of supplementation to the 7 day follow up visit
Resilience behavior (Wagnild &Young)
Resilience scale (Wagnild \&Young): self-reported 25-item scale to assess overall resilience
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Spermidine blood concentration
Assessment of spermidine blood Levels by HPLC (high pressure liquid chromatography) analysis
Measured: change from baseline over 21 days of supplementation to 7 day follow up
white cell count
Complete white cell count (per liter)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Hemoglobin
Hemoglobin (g/dL)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Hematocrit
Hematocrit (%)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
red cell count
complete red cell count (per liter)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
MCV
mean corpuscular volume (fl)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
MCH
mean corpuscular hemoglobin (pg)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
thrombocytes
thrombocytes per Liter
Measured: change from baseline over 21 days of supplementation to 7 day follow up
MCHC
mean corpuscular hemoglobin concentration (g/dL)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
RDW
red cell distribution width (%)
Measured: change from baseline over 21 days of supplementation to 7 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Dec 2020
- Primary completion1 Jun 2022
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of different inclusion criteria (healthy or depressive disorder) each group undergoing one out of two conditions (spermidine vs. placebo Supplementation) (randomized)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nils Gassen, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823806
- Sponsor's protocol ID
- StressLess
- Status last verified
- Nov 2022
- First submitted
- 24 Mar 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisenberg T, Knauer H, Schauer A, Buttner S, Ruckenstuhl C, Carmona-Gutierrez D, Ring J, Schroeder S, Magnes C, Antonacci L, Fussi H, Deszcz L, Hartl R, Schraml E, Criollo A, Megalou E, Weiskopf D, Laun P, Heeren G, Breitenbach M, Grubeck-Loebenstein B, Herker E, Fahrenkrog B, Frohlich KU, Sinner F, Tavernarakis N, Minois N, Kroemer G, Madeo F. Induction of autophagy by spermidine promotes longevity. Nat Cell Biol. 2009 Nov;11(11):1305-14. doi: 10.1038/ncb1975. Epub 2009 Oct 4.
PubMed 19801973Madeo F, Eisenberg T, Pietrocola F, Kroemer G. Spermidine in health and disease. Science. 2018 Jan 26;359(6374):eaan2788. doi: 10.1126/science.aan2788.
PubMed 29371440Fond G, Macgregor A, Leboyer M, Michalsen A. Fasting in mood disorders: neurobiology and effectiveness. A review of the literature. Psychiatry Res. 2013 Oct 30;209(3):253-8. doi: 10.1016/j.psychres.2012.12.018. Epub 2013 Jan 15.
PubMed 23332541Galluzzi L, Bravo-San Pedro JM, Levine B, Green DR, Kroemer G. Pharmacological modulation of autophagy: therapeutic potential and persisting obstacles. Nat Rev Drug Discov. 2017 Jul;16(7):487-511. doi: 10.1038/nrd.2017.22. Epub 2017 May 19.
PubMed 28529316Jia J, Le W. Molecular network of neuronal autophagy in the pathophysiology and treatment of depression. Neurosci Bull. 2015 Aug;31(4):427-34. doi: 10.1007/s12264-015-1548-2. Epub 2015 Aug 8.
PubMed 26254058
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autophagy Characterization and Multi-level Molecular Profiling of Spermidine Supplementation: a Clinical Study
- ClinicalTrials.gov ID
- NCT04823806
- Acronym / sponsor ID
- StressLess
- Conditions
- Depression, Healthy
- Keywords
- Spermidine, Autophagy, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patients.Therefore, 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, e.g. for psychiatric patients. Research on spermidine in animal models is limited, but a study with mice overexpressing spermidine/spermine 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 mg/d; 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2 groups of different inclusion criteria (healthy or depressive disorder) each group undergoing one out of two conditions (spermidine vs. placebo Supplementation) (randomized)
| Arm | Type | Receives |
|---|---|---|
| Healthy participants and participants with depressive disorder: dietary spermidine supplementation | Experimental | Dietary Supplement: Spermidine (spermidineLIFE ®) OR PlaceboDietary Supplement: Polyamine 21 days of spermidine supplementation (3 sachets/day = 6mg spermidine/day) |
| Healthy participants and participants with depressive disorder: dietary placebo supplementation | Placebo comparator | Dietary Supplement: Spermidine (spermidineLIFE ®) OR PlaceboDietary Supplement: Placebo 21 days of Placebo supplementation (3 sachets/day) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Present written declaration of consent
- Healty or diagnosed with depression
- BMI between 17 and 40
Key exclusion criteria (5 listed)
- Insufficient linguistic communication
- Pregnancy or lactation
- Gluten, histamine or wheat seedling intolerance
- Drug abuse or alcohol dependency
- Current spermidine substitution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spermidine (spermidineLIFE ®) OR Placebo21 day of 6mg spermidine OR Placebo supplementation per day | Dietary supplement | Healthy participants and participants with depressive disorder: dietary placebo supplementation, Healthy participants and participants with depressive disorder: dietary spermidine supplementation |
Primary outcome
Proteomics and autophagy processes
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting.
25 secondary outcomes
Epigenetic patterns
Time frame: change from baseline to day 21 of supplementation to 7 day follow up
Proteome/phosphoproteome/ubiquitinome patterns
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Metabolic processes
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Lipid profiling
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Exosomal protein patterns
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Glomerular filtration rate
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Cystatin C
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Liver Enzymes
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
White blood cell differential
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Saliva Cortisol Levels (dexamethasone suppression test)
Time frame: on day 19 and 20 of supplementation
Sleep Efficiency
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Overall sleep Quality
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Sleep Quality (PSQI)
Time frame: Change from baseline to day 7 day follow up visit
Mental well-being (WEMWBS)
Time frame: Change from baseline to day 14 of supplementation to the 7 day follow up visit
Resilience behavior (Wagnild &Young)
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Spermidine blood concentration
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
white cell count
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Hemoglobin
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Hematocrit
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
red cell count
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
MCV
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
MCH
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
thrombocytes
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
MCHC
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
RDW
Time frame: change from baseline over 21 days of supplementation to 7 day follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Results publication: PubMed 19801973Eisenberg T, Knauer H, Schauer A, Buttner S, Ruckenstuhl C, Carmona-Gutierrez D, Ring J, Schroeder S, Magnes C, Antonacci L, Fussi H, Deszcz L, Hartl R, Schraml E, Criollo A, Megalou E, Weiskopf D, Laun P, Heeren G, Breitenbach M, Grubeck-Loebenstein B, Herker E, Fahrenkrog B, Frohlich KU, Sinner F, Tavernarakis N, Minois N, Kroemer G, Madeo F. Induction of autophagy by spermidine promotes longevity. Nat Cell Biol. 2009 Nov;11(11):1305-14. doi: 10.1038/ncb1975. Epub 2009 Oct 4.
- Results publication: PubMed 29371440Madeo F, Eisenberg T, Pietrocola F, Kroemer G. Spermidine in health and disease. Science. 2018 Jan 26;359(6374):eaan2788. doi: 10.1126/science.aan2788.
- Results publication: PubMed 23332541Fond G, Macgregor A, Leboyer M, Michalsen A. Fasting in mood disorders: neurobiology and effectiveness. A review of the literature. Psychiatry Res. 2013 Oct 30;209(3):253-8. doi: 10.1016/j.psychres.2012.12.018. Epub 2013 Jan 15.
- Results publication: PubMed 28529316Galluzzi L, Bravo-San Pedro JM, Levine B, Green DR, Kroemer G. Pharmacological modulation of autophagy: therapeutic potential and persisting obstacles. Nat Rev Drug Discov. 2017 Jul;16(7):487-511. doi: 10.1038/nrd.2017.22. Epub 2017 May 19.
- Results publication: PubMed 26254058Jia J, Le W. Molecular network of neuronal autophagy in the pathophysiology and treatment of depression. Neurosci Bull. 2015 Aug;31(4):427-34. doi: 10.1007/s12264-015-1548-2. Epub 2015 Aug 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Depression and Healthy, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomics and autophagy processes (time frame: change from baseline over 21 days of supplementation to 7 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823806, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.