Clinical trial NCT06016530: Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study
Official title: Multi-level Molecular Profiling of Stress Exposure Under Standardized Food Intake: A Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Related Disorder
Nutrition, Healthy
Metabolism
Keywords: Stress Related Disorders
Nutrition
Metabolism
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Present written declaration of consent
* Healthy
* BMI between 18 and 30

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proteomics and Autophagy Processes
timeFrame: 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:
measure: Metabolic Processes
timeFrame: 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.
measure: Lipid Profiling
timeFrame: 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.
measure: Saliva Cortisol Levels
timeFrame: 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.
measure: The Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
timeFrame: 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.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 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.
measure: Resilience Scale (Wagnild &Young)
timeFrame: 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.
measure: STROOP test
timeFrame: 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.
measure: N-Back test
timeFrame: 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.
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn, Department of Psychiatry and Psychotherapy
state: North Rhine-Westphalia
Study officials:
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