NCT06016530

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Dr. Nils Gassen · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stress Related Disorder
• Nutrition, Healthy
• Metabolism

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Deprivation	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).
DRUG	Dexamethasone Supplementation	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).

Timeline

• Start date: 2023-03-21
• Primary completion: 2024-12-31
• Completion: 2025-03-01
• First posted: 2023-08-29
• Last updated: 2023-08-29

Locations

1 site across 1 country: Germany