Stress Related DisorderNCT06016530
Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study
A study testing Sleep Deprivation and Dexamethasone Supplementation in people with Stress Related Disorder and Nutrition, Healthy, run by Dr. Nils Gassen at 1 site in Germany.
Trial summary
Nutrition plays a crucial role in preventing various diseases, including cardiovascular and metabolic conditions. Moreover, it is gaining increasing attention in the context of preventing and treating psychiatric disorders. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Related Disorder, Nutrition, Healthy, Metabolism
- What is being tested?
- Sleep Deprivation and Dexamethasone Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 21 Mar 2023to 1 Mar 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Present written declaration of consent
- Healthy
- BMI between 18 and 30
Who cannot join
- Insufficient linguistic communication
- Drug abuse or alcohol dependency
- Smoker
- Hormonal contraception
- Neurological condition or epilepsy in the medical history
- Regular medication except for L-thyroxine or antihistamines
- A known disease of the cardiovascular system, hypertension higher than 160/90mmHg
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn, Department of Psychiatry and Psychotherapy
Bonn, North Rhine-Westphalia, 53127
Nils Gassen C. Gassen, Dr., 0228-287-15793, nils.gassen@ukbonn.de
About this study
Nutrition plays a crucial role in preventing various diseases, including cardiovascular and metabolic conditions. Moreover, it is gaining increasing attention in the context of preventing and treating psychiatric disorders. However, limited knowledge exists concerning the effects of food intake and stress on metabolism over time.
To enhance the understanding of this subject, blood components in healthy volunteers will be examined during a standardized diet, focusing on the interaction between nutrition and stress. Physiological stress will be induced by subjecting participants to sleep deprivation for over 36 hours. Hormonal influences related to the female menstrual cycle are particularly taken into account in female participants.
In conclusion, comprehending these processes can improve the understanding of nutritional physiology and contribute to advancements in clinical practice.
Read the detailed description
Nutrition is crucial in preventing cardiovascular, metabolic, and other diseases, and its significance in psychiatric disorders is growing. It plays a key role in maintaining health and can be a low-risk, cost-effective therapy in early disease stages.
Observational studies suggest that healthy eating habits, such as the Mediterranean diet, positively affect inflammation markers. However, the exact molecular processes during food intake remain limited to observational studies due to the complexity of involved factors. Moreover, the effects of food intake and stress on metabolism over time are poorly understood.
A comprehensive molecular analysis during a standardized diet is crucial for understanding nutrition's role in disease treatment and advancing nutritional analyses in clinical practice. By utilizing a "multi-omics approach," it becomes possible to study changes in various molecular groups, such as proteins or lipids, and investigate the underlying mechanisms of diseases.
For this purpose, a cohort of 20 to 30 healthy individuals, encompassing around 15 females and 15 males, will be recruited. Initially, all participants will undergo a baseline measurement, profiling their blood components while adhering to a standardized diet. Subsequently, the same participants will be subjected to a physiological stressor involving 36 hours of sleep deprivation. Lastly, the participants will receive dexamethasone as a pharmacological stressor. Throughout these stages, the primary focus centers on examining the interaction between nutrition and stress at a metabolic level.
The main goal of the study is to improve comprehension of the molecular mechanisms associated with food intake and stress, and their impact on metabolism.
- Conditions
- Stress Related Disorder, Nutrition, Healthy, Metabolism
- Being tested
- Sleep Deprivation, Dexamethasone Supplementation
- Keywords
- Stress Related Disorders, Nutrition, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DeprivationBehavioural
During a sleep deprivation period lasting over 36 hours, individual fluctuations of various metabolites will be measured throughout the day (12 hours) for each participant while adhering to a standardized diet. To achieve this, blood samples will be collected and processed into plasma or peripheral blood mononuclear cells (PBMCs).
Dexamethasone SupplementationDrug
Dexamethasone belongs to the drug class of corticosteroids. It is a synthetic glucocorticoid that activates glucocorticoid receptor (GR) and the hypothalamic-pituitary-adrenal (HPA) axis selectively.
Following the administration of 1 mg of dexamethasone as a pharmacological stressor, individual fluctuations of various metabolites will be measured throughout the day (12 hours) for each participant under a standardized diet. To facilitate this, blood samples will be collected and processed into plasma or peripheral blood mononuclear cells (PBMCs).
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | The study will involve 20 to 30 healthy participants, with approximately 15 females and 15 males. Each participant will undergo three measurements: 1) Baseline assessment, 2) Sleep Deprivation, and 3) Dexamethasone Supplementation.
The baseline measurement will be the starting point taken before any interventions are applied. It will serve as a control and reference to evaluate the impact of interventions. Receives: Behavioral: Sleep Deprivation; Drug: Dexamethasone Supplementation |
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) in isolated PBMCs (peripheral blood mononuclear cells) using Western Blotting.
Measured: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (7 blood withdrawals every two hours; at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m.). These measurements will be repeated after the two interventions.
Secondary outcomes (8)
Metabolic Processes
Metabolic measurements will be conducted using mass spectrometry, a technique that identifies and quantifies molecules based on their mass-to-charge ratio. The units for these measurements will be expressed in molar concentrations (e.g., µM or mM).
Measured: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (7 blood withdrawals every two hours; at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m.). These measurements will be repeated after the two interventions.
Lipid Profiling
Targeted and quantitative analysis by mass spectrometry of changes in plasma lipids. The units for lipid concentrations will be reported in mass units (nmol/mL)
Measured: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (7 blood withdrawals every two hours; at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m.). These measurements will be repeated after the two interventions.
Saliva Cortisol Levels
Saliva Cortisol Levels in nmol per Liter (nmol/L) after dexamethasone intake will be evaluated and compared to the control group.
Measured: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (hourly: 7 a.m., 8 a.m., 9 a.m., 10 a.m., 11 a.m., 12 p.m., 1 p.m., 2 p.m., 3 p.m., 4 p.m., 5 p.m., 6 p.m., 7 p.m.) These measurements will be repeated after the two interventions.
The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) was developed by researchers to measure the mental well-being of adults. WEMWBS is a 14-item scale covering subjective well-being and psychological functioning. All items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item, answered on a 1 to 5 Likert scale. The minimum score is 14 and the maximum is 70.
Measured: The assessments will be conducted twice: at the beginning before baseline measurements, and again before the final intervention. This approach allows for a comparison between the initial state and the state before the final intervention.
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire assessing sleep quality over a 1-month interval. The measure consists of 19 items, creating 7 components that produce one global score. It takes 5-10 minutes to complete. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with lower scores indicating better sleep quality.
Measured: The assessments will be conducted twice: at the beginning before baseline measurements, and again before the final intervention. This approach allows for a comparison between the initial state and the state before the final intervention.
Resilience Scale (Wagnild &Young)
The Resilience Scale is a self-reported 25-item scale to assess overall resilience. A higher score means a better resilience. Scores range from 25 to 175 points.
Measured: The assessments will be conducted twice: at the beginning before baseline measurements, and again before the final intervention. This approach allows for a comparison between the initial state and the state before the final intervention.
STROOP test
The Stroop test is a cognitive task where participants must name the ink color of words while ignoring the actual word meaning. It measures response inhibition and cognitive flexibility. The measure is typically the time taken to complete the task (in seconds), with higher values indicating worse cognitive performance.
Measured: The changes will be measured every two hours throughout the day between 7 a.m. and 7 p.m. The test will be conducted at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m. This testing schedule will be repeated for all the interventions.
N-Back test
The N-Back test is a cognitive task that assesses working memory and attention. Participants are required to indicate whether a current stimulus matches the one presented 'N' steps back in a sequence. Scores are reported as a percentage of correct responses, with higher percentages indicating better cognitive performance.
Measured: The changes will be measured every two hours throughout the day between 7 a.m. and 7 p.m. The test will be conducted at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m. This testing schedule will be repeated for all the interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start21 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Stress Related DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- One group; all participants will undergo identical measurements, including: 1) Baseline assessment, 2) Sleep Deprivation, and 3) Dexamethasone Supplementation.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Nils Gassen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Nils Gassen, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016530
- Sponsor's protocol ID
- 084/22
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be anonymized, so that no participant will suffer any disadvantage.
Publications
Bastard JP, Jardel C, Bruckert E, Blondy P, Capeau J, Laville M, Vidal H, Hainque B. Elevated levels of interleukin 6 are reduced in serum and subcutaneous adipose tissue of obese women after weight loss. J Clin Endocrinol Metab. 2000 Sep;85(9):3338-42. doi: 10.1210/jcem.85.9.6839.
PubMed 10999830Berthelot E, Etchecopar-Etchart D, Thellier D, Lancon C, Boyer L, Fond G. Fasting Interventions for Stress, Anxiety and Depressive Symptoms: A Systematic Review and Meta-Analysis. Nutrients. 2021 Nov 5;13(11):3947. doi: 10.3390/nu13113947.
PubMed 34836202Bowen KJ, Sullivan VK, Kris-Etherton PM, Petersen KS. Nutrition and Cardiovascular Disease-an Update. Curr Atheroscler Rep. 2018 Jan 30;20(2):8. doi: 10.1007/s11883-018-0704-3.
PubMed 29383458Draper CF, Duisters K, Weger B, Chakrabarti A, Harms AC, Brennan L, Hankemeier T, Goulet L, Konz T, Martin FP, Moco S, van der Greef J. Menstrual cycle rhythmicity: metabolic patterns in healthy women. Sci Rep. 2018 Oct 1;8(1):14568. doi: 10.1038/s41598-018-32647-0.
PubMed 30275458Estruch R. Anti-inflammatory effects of the Mediterranean diet: the experience of the PREDIMED study. Proc Nutr Soc. 2010 Aug;69(3):333-40. doi: 10.1017/S0029665110001539. Epub 2010 Jun 2.
PubMed 20515519Hamdy O, Barakatun-Nisak MY. Nutrition in Diabetes. Endocrinol Metab Clin North Am. 2016 Dec;45(4):799-817. doi: 10.1016/j.ecl.2016.06.010.
PubMed 27823606Leonard BE. Inflammation and depression: a causal or coincidental link to the pathophysiology? Acta Neuropsychiatr. 2018 Feb;30(1):1-16. doi: 10.1017/neu.2016.69. Epub 2017 Jan 23.
PubMed 28112061Locke A, Schneiderhan J, Zick SM. Diets for Health: Goals and Guidelines. Am Fam Physician. 2018 Jun 1;97(11):721-728.
PubMed 30215930Marx W, Moseley G, Berk M, Jacka F. Nutritional psychiatry: the present state of the evidence. Proc Nutr Soc. 2017 Nov;76(4):427-436. doi: 10.1017/S0029665117002026. Epub 2017 Sep 25.
PubMed 28942748Ravera A, Carubelli V, Sciatti E, Bonadei I, Gorga E, Cani D, Vizzardi E, Metra M, Lombardi C. Nutrition and Cardiovascular Disease: Finding the Perfect Recipe for Cardiovascular Health. Nutrients. 2016 Jun 14;8(6):363. doi: 10.3390/nu8060363.
PubMed 27314382Ridker PM, Buring JE, Cook NR, Rifai N. C-reactive protein, the metabolic syndrome, and risk of incident cardiovascular events: an 8-year follow-up of 14 719 initially healthy American women. Circulation. 2003 Jan 28;107(3):391-7. doi: 10.1161/01.cir.0000055014.62083.05.
PubMed 12551861Sanner T. Formation of transient complexes in the glutamate dehydrogenase catalyzed reaction. Biochemistry. 1975 Nov 18;14(23):5094-8. doi: 10.1021/bi00694a011.
PubMed 39Wallace M, Hashim YZ, Wingfield M, Culliton M, McAuliffe F, Gibney MJ, Brennan L. Effects of menstrual cycle phase on metabolomic profiles in premenopausal women. Hum Reprod. 2010 Apr;25(4):949-56. doi: 10.1093/humrep/deq011. Epub 2010 Feb 10.
PubMed 20150174Watzl B, Kulling SE, Moseneder J, Barth SW, Bub A. A 4-wk intervention with high intake of carotenoid-rich vegetables and fruit reduces plasma C-reactive protein in healthy, nonsmoking men. Am J Clin Nutr. 2005 Nov;82(5):1052-8. doi: 10.1093/ajcn/82.5.1052.
PubMed 16280438
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study
- ClinicalTrials.gov ID
- NCT06016530
- Acronym / sponsor ID
- 084/22
- Conditions
- Stress Related Disorder, Nutrition, Healthy, Metabolism
- Keywords
- Stress Related Disorders, Nutrition, Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dr. Nils GassenUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 29 Aug 2023 (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.
Nutrition plays a crucial role in preventing various diseases, including cardiovascular and metabolic conditions. Moreover, it is gaining increasing attention in the context of preventing and treating psychiatric disorders. However, limited knowledge exists concerning the effects of food intake and stress on metabolism over time.
To enhance the understanding of this subject, blood components in healthy volunteers will be examined during a standardized diet, focusing on the interaction between nutrition and stress. Physiological stress will be induced by subjecting participants to sleep deprivation for over 36 hours. Hormonal influences related to the female menstrual cycle are particularly taken into account in female participants.
In conclusion, comprehending these processes can improve the understanding of nutritional physiology and contribute to advancements in clinical practice.
Detailed description
Nutrition is crucial in preventing cardiovascular, metabolic, and other diseases, and its significance in psychiatric disorders is growing. It plays a key role in maintaining health and can be a low-risk, cost-effective therapy in early disease stages.
Observational studies suggest that healthy eating habits, such as the Mediterranean diet, positively affect inflammation markers. However, the exact molecular processes during food intake remain limited to observational studies due to the complexity of involved factors. Moreover, the effects of food intake and stress on metabolism over time are poorly understood.
A comprehensive molecular analysis during a standardized diet is crucial for understanding nutrition's role in disease treatment and advancing nutritional analyses in clinical practice. By utilizing a "multi-omics approach," it becomes possible to study changes in various molecular groups, such as proteins or lipids, and investigate the underlying mechanisms of diseases.
For this purpose, a cohort of 20 to 30 healthy individuals, encompassing around 15 females and 15 males, will be recruited. Initially, all participants will undergo a baseline measurement, profiling their blood components while adhering to a standardized diet. Subsequently, the same participants will be subjected to a physiological stressor involving 36 hours of sleep deprivation. Lastly, the participants will receive dexamethasone as a pharmacological stressor. Throughout these stages, the primary focus centers on examining the interaction between nutrition and stress at a metabolic level.
The main goal of the study is to improve comprehension of the molecular mechanisms associated with food intake and stress, and their impact on metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group; all participants will undergo identical measurements, including: 1) Baseline assessment, 2) Sleep Deprivation, and 3) Dexamethasone Supplementation.
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Behavioral: Sleep Deprivation, Drug: Dexamethasone SupplementationThe study will involve 20 to 30 healthy participants, with approximately 15 females and 15 males. Each participant will undergo three measurements: 1) Baseline assessment, 2) Sleep Deprivation, and 3) Dexamethasone Supplementation. The baseline measurement will be the starting point taken before any interventions are applied. It will serve as a control and reference to evaluate the impact of interventions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Present written declaration of consent
- Healthy
- BMI between 18 and 30
Key exclusion criteria (7 listed)
- Insufficient linguistic communication
- Drug abuse or alcohol dependency
- Smoker
- Hormonal contraception
- Neurological condition or epilepsy in the medical history
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 |
|---|---|---|
| Sleep DeprivationDuring a sleep deprivation period lasting over 36 hours, individual fluctuations of various metabolites will be measured throughout the day (12 hours) for each participant while adhering to a standardized diet. To achieve this, blood samples will be collected and processed into plasma or peripheral blood mononuclear cells (PBMCs). | Behavioural | Healthy participants |
| Dexamethasone SupplementationDexamethasone belongs to the drug class of corticosteroids. It is a synthetic glucocorticoid that activates glucocorticoid receptor (GR) and the hypothalamic-pituitary-adrenal (HPA) axis selectively. Following the administration of 1 mg of dexamethasone as a pharmacological stressor, individual fluctuations of various metabolites will be measured throughout the day (12 hours) for each participant under a standardized diet. To facilitate this, blood samples will be collected and processed into plasma or peripheral blood mononuclear cells (PBMCs). | Drug | Healthy participants |
Primary outcome
Proteomics and Autophagy Processes
Time frame: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (7 blood withdrawals every two hours; at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m.). These measurements will be repeated after the two interventions.
Change in protein levels of autophagy biomarkers (LC3II \& p62) in isolated PBMCs (peripheral blood mononuclear cells) using Western Blotting.
8 secondary outcomes
Metabolic Processes
Time frame: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (7 blood withdrawals every two hours; at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m.). These measurements will be repeated after the two interventions.
Lipid Profiling
Time frame: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (7 blood withdrawals every two hours; at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m.). These measurements will be repeated after the two interventions.
Saliva Cortisol Levels
Time frame: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (hourly: 7 a.m., 8 a.m., 9 a.m., 10 a.m., 11 a.m., 12 p.m., 1 p.m., 2 p.m., 3 p.m., 4 p.m., 5 p.m., 6 p.m., 7 p.m.) These measurements will be repeated after the two interventions.
The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
Time frame: The assessments will be conducted twice: at the beginning before baseline measurements, and again before the final intervention. This approach allows for a comparison between the initial state and the state before the final intervention.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: The assessments will be conducted twice: at the beginning before baseline measurements, and again before the final intervention. This approach allows for a comparison between the initial state and the state before the final intervention.
Resilience Scale (Wagnild &Young)
Time frame: The assessments will be conducted twice: at the beginning before baseline measurements, and again before the final intervention. This approach allows for a comparison between the initial state and the state before the final intervention.
STROOP test
Time frame: The changes will be measured every two hours throughout the day between 7 a.m. and 7 p.m. The test will be conducted at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m. This testing schedule will be repeated for all the interventions.
N-Back test
Time frame: The changes will be measured every two hours throughout the day between 7 a.m. and 7 p.m. The test will be conducted at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m. This testing schedule will be repeated for all the interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 10999830Bastard JP, Jardel C, Bruckert E, Blondy P, Capeau J, Laville M, Vidal H, Hainque B. Elevated levels of interleukin 6 are reduced in serum and subcutaneous adipose tissue of obese women after weight loss. J Clin Endocrinol Metab. 2000 Sep;85(9):3338-42. doi: 10.1210/jcem.85.9.6839.
- Background: PubMed 34836202Berthelot E, Etchecopar-Etchart D, Thellier D, Lancon C, Boyer L, Fond G. Fasting Interventions for Stress, Anxiety and Depressive Symptoms: A Systematic Review and Meta-Analysis. Nutrients. 2021 Nov 5;13(11):3947. doi: 10.3390/nu13113947.
- Background: PubMed 29383458Bowen KJ, Sullivan VK, Kris-Etherton PM, Petersen KS. Nutrition and Cardiovascular Disease-an Update. Curr Atheroscler Rep. 2018 Jan 30;20(2):8. doi: 10.1007/s11883-018-0704-3.
- Background: PubMed 30275458Draper CF, Duisters K, Weger B, Chakrabarti A, Harms AC, Brennan L, Hankemeier T, Goulet L, Konz T, Martin FP, Moco S, van der Greef J. Menstrual cycle rhythmicity: metabolic patterns in healthy women. Sci Rep. 2018 Oct 1;8(1):14568. doi: 10.1038/s41598-018-32647-0.
- Background: PubMed 20515519Estruch R. Anti-inflammatory effects of the Mediterranean diet: the experience of the PREDIMED study. Proc Nutr Soc. 2010 Aug;69(3):333-40. doi: 10.1017/S0029665110001539. Epub 2010 Jun 2.
- Background: PubMed 27823606Hamdy O, Barakatun-Nisak MY. Nutrition in Diabetes. Endocrinol Metab Clin North Am. 2016 Dec;45(4):799-817. doi: 10.1016/j.ecl.2016.06.010.
- Background: PubMed 28112061Leonard BE. Inflammation and depression: a causal or coincidental link to the pathophysiology? Acta Neuropsychiatr. 2018 Feb;30(1):1-16. doi: 10.1017/neu.2016.69. Epub 2017 Jan 23.
- Background: PubMed 30215930Locke A, Schneiderhan J, Zick SM. Diets for Health: Goals and Guidelines. Am Fam Physician. 2018 Jun 1;97(11):721-728.
- Background: PubMed 28942748Marx W, Moseley G, Berk M, Jacka F. Nutritional psychiatry: the present state of the evidence. Proc Nutr Soc. 2017 Nov;76(4):427-436. doi: 10.1017/S0029665117002026. Epub 2017 Sep 25.
- Background: PubMed 27314382Ravera A, Carubelli V, Sciatti E, Bonadei I, Gorga E, Cani D, Vizzardi E, Metra M, Lombardi C. Nutrition and Cardiovascular Disease: Finding the Perfect Recipe for Cardiovascular Health. Nutrients. 2016 Jun 14;8(6):363. doi: 10.3390/nu8060363.
- Background: PubMed 12551861Ridker PM, Buring JE, Cook NR, Rifai N. C-reactive protein, the metabolic syndrome, and risk of incident cardiovascular events: an 8-year follow-up of 14 719 initially healthy American women. Circulation. 2003 Jan 28;107(3):391-7. doi: 10.1161/01.cir.0000055014.62083.05.
- Background: PubMed 39Sanner T. Formation of transient complexes in the glutamate dehydrogenase catalyzed reaction. Biochemistry. 1975 Nov 18;14(23):5094-8. doi: 10.1021/bi00694a011.
- Individual participant dataSharing planned: No. All data will be anonymized, so that no participant will suffer any disadvantage.
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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.
University Hospital Bonn, Department of Psychiatry and Psychotherapy
Bonn, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Deprivation and Dexamethasone Supplementation in people with Stress Related Disorder and Nutrition, Healthy, run by Dr. Nils Gassen 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 7 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 29 Aug 2023. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomics and Autophagy Processes (time frame: Changes will be measured throughout one day between 7 a.m. and 7 p.m. (7 blood withdrawals every two hours; at 7 a.m., 9 a.m., 11 a.m., 1 p.m., 3 p.m., 5 p.m., and 7 p.m.). These measurements will be repeated after the two interventions.). 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 NCT06016530, which also lists 14 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 29 Aug 2023.