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

Dr. Nils Gassen

Status: Enrolling

Conditions: Metabolism; Stress Related Disorder; Nutrition, Healthy

Treatments: Behavioral: Sleep Deprivation; Drug: Dexamethasone Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06016530

084/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Healthy participants

Experimental group

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.

Treatment:

Drug: Dexamethasone Supplementation

Behavioral: Sleep Deprivation