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Trial · NCT06016530

Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study

NCT06016530, Not applicable, Unknown, Dr. Nils Gassen

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study. Trials, record NCT06016530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06016530

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study
NCT number
NCT06016530
Status
Unknown
Phases
Not applicable
Enrollment
30 participants, estimated
Lead sponsor
Dr. Nils Gassen
Conditions
Stress Related Disorder, Nutrition, Healthy, Metabolism
Interventions
Sleep Deprivation, Dexamethasone Supplementation
First posted
2023-08-29
Last updated
2023-08-29

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProteomics and Autophagy Processes
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.
SecondaryMetabolic Processes
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.
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).
SecondaryLipid Profiling
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.
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)
SecondarySaliva Cortisol Levels
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.
Saliva Cortisol Levels in nmol per Liter (nmol/L) after dexamethasone intake will be evaluated and compared to the control group.
SecondaryThe Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
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.
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.
SecondaryPittsburgh Sleep Quality Index (PSQI)
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.
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.
SecondaryResilience Scale (Wagnild &Young)
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.
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.
SecondarySTROOP test
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.
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.
SecondaryN-Back test
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.
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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers14

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
39BACKGROUNDPubMed
10999830BACKGROUNDPubMed
12551861BACKGROUNDPubMed
16280438BACKGROUNDPubMed
20150174BACKGROUNDPubMed
20515519BACKGROUNDPubMed
27314382BACKGROUNDPubMed
27823606BACKGROUNDPubMed
28112061BACKGROUNDPubMed
28942748BACKGROUNDPubMed

1 to 10 of 14

See all 14 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
1-Back TaskSecondary outcomeConductCognition
2-Back TaskSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06016530

GET https://conductscience.org/api/trials/v1/NCT06016530/registered