Temporal Genomics Mechanisms Underlying Disease and Aging

NCT ID: NCT03637751

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-21
• Study Completion Date: 2021-06-30

Brief Summary

Given the salient role of early-life adversity and the resulting biological embedding in disease risk, there is a critical need to understand the mechanisms operating at multiple levels of analysis in order to promote effective clinical treatments and intervention efforts for survivors. An example for such an effort could be to utilize models of dynamic cellular markers as individual-level factors to account for variation in intervention response and clinical outcomes. Results of this study will lead to new knowledge about specific gene expression pathways in response to stress, and whether the response is moderated by previous exposure to early adversity, shorter telomere length (a marker of cellular aging) and self-report mental-health measures. Thus, the long-term effects of this study will advance our understanding on stress-related transcriptomic changes that play a downstream role in disease susceptibility and accelerated aging, with the goal of targeting specific pathways and genes for potential intervention studies and pharmacological treatments to reverse the effects of exposure to early adversity. For example, considering high failure rates for depression treatments, and in order to tailor individual interventions, identifying objective changes in stress-induced gene expression may help to predict intervention efficacy in clinical and non-clinical settings, as seen, for example, in breast and leukemia cancers. Thus, findings will have a range of impacts for basic science, intervention studies and clinical practice that will influence treatments to match the specific cellular processes operating within an individual.

Conditions

Gene Expression in Response to Acute Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Experimental design

Testing will be carried out in Penn State's Clinical Research Center (CRC). The CRC has rooms for conducting the Trier Social Stress Test (TSST) stress-task and for resting. Participants will make two visits to the CRC, one week apart, on the same day of the weekday. Sessions will be scheduled from 11:00 am to 4:15 pm. We will use a randomized counter-balanced order for the two sessions (i.e., TSST and control conditions) with group membership blind to the subjects and lab personnel.

Group Type: EXPERIMENTAL

Behavioral

Intervention Type: BEHAVIORAL

Trier Social Stress Test

Control design

In the no-stress control condition, participants will be instructed to sit in a room, read magazines, and to refrain from any stressful activities (e.g., cell-phone use will be restricted).

Group Type: EXPERIMENTAL

Control condition

Intervention Type: BEHAVIORAL

In the no-stress control condition, participants will be instructed to sit in a room, read magazines, and to refrain from any stressful activities (e.g., cell-phone use will be restricted).

Interventions

Behavioral

Trier Social Stress Test

Intervention Type: BEHAVIORAL

Control condition

In the no-stress control condition, participants will be instructed to sit in a room, read magazines, and to refrain from any stressful activities (e.g., cell-phone use will be restricted).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18-25
• Without significant medical illness or endocrine illness (for example, asthma, diabetes, thyroid disease or pituitary gland disorders)
• Currently non-smokers
• Not pregnant and had not given birth in the past year
• Not using medication on a regular basis besides oral contraceptives to allow generalizability to adult women.

Exclusion Criteria

• Recent infection or illness
• Use of abused drugs
• Immune disease, ascertained during the phone interview.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Idan Shalev

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biobehavioral Health Building

University Park, Pennsylvania, United States

Countries

United States

Other Identifiers

1R21AG055621-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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