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

NCT06016530 | Unknown

• 1 other identifier: 084/22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Related Disorder; Nutrition, Healthy; Metabolism

Keywords

Stress Related Disorders; Nutrition; Metabolism

Outcome Measures

Primary Outcomes (1)

• Proteomics and Autophagy Processes

  Change in protein levels of autophagy biomarkers (LC3II \& p62) in isolated PBMCs (peripheral blood mononuclear cells) using Western Blotting.

  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 (8)

• Metabolic 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.

• Lipid 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.

• Saliva 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.

• The 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.

• Pittsburgh 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.

Study Arms (1)

Healthy participants

EXPERIMENTAL

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.

Behavioral: Sleep Deprivation; Drug: Dexamethasone Supplementation

Interventions

Sleep Deprivation BEHAVIORAL

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).

Healthy participants

Dexamethasone Supplementation DRUG

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).

Healthy participants

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Nils Gassen: lead

Study Sites (1)

University Hospital Bonn, Department of Psychiatry and Psychotherapy

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Related Publications (14)

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  PMID: 16280438 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group; all participants will undergo identical measurements, including: 1) Baseline assessment, 2) Sleep Deprivation, and 3) Dexamethasone Supplementation.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 29, 2023
• Study Start: March 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)