MedTrace Logo

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

NCT06016530 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-29

No results posted yet for this study

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.

Conditions

  • Stress Related Disorder
  • Nutrition, Healthy
  • Metabolism

Interventions

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).

Sponsors & Collaborators

  • Dr. Nils Gassen

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2024-12-31
Completion
2025-03-01

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06016530 on ClinicalTrials.gov