xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06016530</url>
    </required_header>
    <id_info>
      <org_study_id>084/22</org_study_id>
      <nct_id>NCT06016530</nct_id>
    </id_info>
    <brief_title>Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study</brief_title>
    <official_title>Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr. Nils Gassen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Bonn</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Nutrition plays a crucial role in preventing various diseases, including cardiovascular and&#xD;
        metabolic conditions. Moreover, it is gaining increasing attention in the context of&#xD;
        preventing and treating psychiatric disorders. However, limited knowledge exists concerning&#xD;
        the effects of food intake and stress on metabolism over time.&#xD;
  &#xD;
        To enhance the understanding of this subject, blood components in healthy volunteers will be&#xD;
        examined during a standardized diet, focusing on the interaction between nutrition and&#xD;
        stress. Physiological stress will be induced by subjecting participants to sleep deprivation&#xD;
        for over 36 hours. Hormonal influences related to the female menstrual cycle are particularly&#xD;
        taken into account in female participants.&#xD;
  &#xD;
        In conclusion, comprehending these processes can improve the understanding of nutritional&#xD;
        physiology and contribute to advancements in clinical practice.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nutrition is crucial in preventing cardiovascular, metabolic, and other diseases, and its&#xD;
        significance in psychiatric disorders is growing. It plays a key role in maintaining health&#xD;
        and can be a low-risk, cost-effective therapy in early disease stages.&#xD;
  &#xD;
        Observational studies suggest that healthy eating habits, such as the Mediterranean diet,&#xD;
        positively affect inflammation markers. However, the exact molecular processes during food&#xD;
        intake remain limited to observational studies due to the complexity of involved factors.&#xD;
        Moreover, the effects of food intake and stress on metabolism over time are poorly&#xD;
        understood.&#xD;
  &#xD;
        A comprehensive molecular analysis during a standardized diet is crucial for understanding&#xD;
        nutrition's role in disease treatment and advancing nutritional analyses in clinical&#xD;
        practice. By utilizing a &quot;multi-omics approach,&quot; it becomes possible to study changes in&#xD;
        various molecular groups, such as proteins or lipids, and investigate the underlying&#xD;
        mechanisms of diseases.&#xD;
  &#xD;
        For this purpose, a cohort of 20 to 30 healthy individuals, encompassing around 15 females&#xD;
        and 15 males, will be recruited. Initially, all participants will undergo a baseline&#xD;
        measurement, profiling their blood components while adhering to a standardized diet.&#xD;
        Subsequently, the same participants will be subjected to a physiological stressor involving&#xD;
        36 hours of sleep deprivation. Lastly, the participants will receive dexamethasone as a&#xD;
        pharmacological stressor. Throughout these stages, the primary focus centers on examining the&#xD;
        interaction between nutrition and stress at a metabolic level.&#xD;
  &#xD;
        The main goal of the study is to improve comprehension of the molecular mechanisms associated&#xD;
        with food intake and stress, and their impact on metabolism.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 21, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>One group; all participants will undergo identical measurements, including: 1) Baseline assessment, 2) Sleep Deprivation, and 3) Dexamethasone Supplementation.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proteomics and Autophagy Processes</measure>
      <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.</time_frame>
      <description>Change in protein levels of autophagy biomarkers (LC3II &amp; p62) in isolated PBMCs (peripheral blood mononuclear cells) using Western Blotting.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Metabolic Processes</measure>
      <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.</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lipid Profiling</measure>
      <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.</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Saliva Cortisol Levels</measure>
      <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.</time_frame>
      <description>Saliva Cortisol Levels in nmol per Liter (nmol/L) after dexamethasone intake will be evaluated and compared to the control group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)</measure>
      <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.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <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.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resilience Scale (Wagnild &amp;Young)</measure>
      <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.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>STROOP test</measure>
      <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.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>N-Back test</measure>
      <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.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Stress Related Disorder</condition>
    <condition>Nutrition, Healthy</condition>
    <condition>Metabolism</condition>
    <arm_group>
      <arm_group_label>Healthy participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sleep Deprivation</intervention_name>
      <description>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).</description>
      <arm_group_label>Healthy participants</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone Supplementation</intervention_name>
      <description>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.&#xD;
  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).</description>
      <arm_group_label>Healthy participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Present written declaration of consent&#xD;
  &#xD;
            -  Healthy&#xD;
  &#xD;
            -  BMI between 18 and 30&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Insufficient linguistic communication&#xD;
  &#xD;
            -  Drug abuse or alcohol dependency&#xD;
  &#xD;
            -  Smoker&#xD;
  &#xD;
            -  Hormonal contraception&#xD;
  &#xD;
            -  Neurological condition or epilepsy in the medical history&#xD;
  &#xD;
            -  Regular medication except for L-thyroxine or antihistamines&#xD;
  &#xD;
            -  A known disease of the cardiovascular system, hypertension higher than 160/90mmHg&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University Hospital Bonn, Department of Psychiatry and Psychotherapy</name>
        <address>
          <city>Bonn</city>
          <state>North Rhine-Westphalia</state>
          <zip>53127</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nils Gassen C. Gassen, Dr.</last_name>
        <phone>0228-287-15793</phone>
        <email>nils.gassen@ukbonn.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>10999830</PMID>
    </reference>
    <reference>
      <citation>Berthelot 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.</citation>
      <PMID>34836202</PMID>
    </reference>
    <reference>
      <citation>Bowen 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.</citation>
      <PMID>29383458</PMID>
    </reference>
    <reference>
      <citation>Draper 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. Erratum In: Sci Rep. 2019 Apr 3;9(1):5797.</citation>
      <PMID>30275458</PMID>
    </reference>
    <reference>
      <citation>Estruch 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.</citation>
      <PMID>20515519</PMID>
    </reference>
    <reference>
      <citation>Hamdy 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.</citation>
      <PMID>27823606</PMID>
    </reference>
    <reference>
      <citation>Leonard 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.</citation>
      <PMID>28112061</PMID>
    </reference>
    <reference>
      <citation>Locke A, Schneiderhan J, Zick SM. Diets for Health: Goals and Guidelines. Am Fam Physician. 2018 Jun 1;97(11):721-728.</citation>
      <PMID>30215930</PMID>
    </reference>
    <reference>
      <citation>Marx 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.</citation>
      <PMID>28942748</PMID>
    </reference>
    <reference>
      <citation>Ravera 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.</citation>
      <PMID>27314382</PMID>
    </reference>
    <reference>
      <citation>Ridker 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.</citation>
      <PMID>12551861</PMID>
    </reference>
    <reference>
      <citation>Sanner T. Formation of transient complexes in the glutamate dehydrogenase catalyzed reaction. Biochemistry. 1975 Nov 18;14(23):5094-8. doi: 10.1021/bi00694a011.</citation>
      <PMID>39</PMID>
    </reference>
    <reference>
      <citation>Wallace 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.</citation>
      <PMID>20150174</PMID>
    </reference>
    <reference>
      <citation>Watzl 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.</citation>
      <PMID>16280438</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Bonn</investigator_affiliation>
      <investigator_full_name>Dr. Nils Gassen</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Stress Related Disorders</keyword>
    <keyword>Nutrition</keyword>
    <keyword>Metabolism</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psychophysiologic Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All data will be anonymized, so that no participant will suffer any disadvantage.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06016530
  org study id: 084/22
  nct id: NCT06016530
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: One group; all participants will undergo identical measurements, including: 1) Baseline assessment, 2) Sleep Deprivation, and 3) Dexamethasone Supplementation.
  primary purpose: Basic Science
  masking: None (Open Label)
  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.
  description: Change in protein levels of autophagy biomarkers (LC3II & p62) in isolated PBMCs (peripheral blood mononuclear cells) using Western Blotting.
  measure: 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.
  description: 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).
  measure: 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.
  description: 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)
  measure: 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.
  description: Saliva Cortisol Levels in nmol per Liter (nmol/L) after dexamethasone intake will be evaluated and compared to the control group.
  measure: 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.
  description: 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.
  measure: 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.
  description: 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.
  measure: 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.
  description: 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.
  measure: 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.
  description: 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.
  measure: 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.
  description: 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.
  arm group label: Healthy participants
  arm group type: Experimental
  description: 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.
  intervention type: Behavioral
  intervention name: Sleep Deprivation
  description: 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).
  arm group label: Healthy participants
  intervention type: Drug
  intervention name: Dexamethasone Supplementation
  description: 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).
  arm group label: Healthy participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  citation: 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.
  PMID: 10999830
  citation: Berthelot 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.
  PMID: 34836202
  citation: Bowen 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.
  PMID: 29383458
  citation: Draper 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. Erratum In: Sci Rep. 2019 Apr 3;9(1):5797.
  PMID: 30275458
  citation: Estruch 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.
  PMID: 20515519
  citation: Hamdy 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.
  PMID: 27823606
  citation: Leonard 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.
  PMID: 28112061
  citation: Locke A, Schneiderhan J, Zick SM. Diets for Health: Goals and Guidelines. Am Fam Physician. 2018 Jun 1;97(11):721-728.
  PMID: 30215930
  citation: Marx 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.
  PMID: 28942748
  citation: Ravera 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.
  PMID: 27314382
  citation: Ridker 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.
  PMID: 12551861
  citation: Sanner T. Formation of transient complexes in the glutamate dehydrogenase catalyzed reaction. Biochemistry. 1975 Nov 18;14(23):5094-8. doi: 10.1021/bi00694a011.
  PMID: 39
  citation: Wallace 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.
  PMID: 20150174
  citation: Watzl 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.
  PMID: 16280438
  responsible party type: Sponsor-Investigator
  investigator affiliation: University Hospital, Bonn
  investigator full name: Dr. Nils Gassen
  investigator title: Principal Investigator
  mesh term: Psychophysiologic Disorders
  mesh term: Dexamethasone
  sharing ipd: No
  ipd description: All data will be anonymized, so that no participant will suffer any disadvantage.