Temporal Genomics Mechanisms Underlying Disease and Aging

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.

Study Overview

• Status: Completed
• Conditions: Gene Expression in Response to Acute Stress
• Intervention / Treatment: Behavioral: Behavioral; Behavioral: Control condition

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Biobehavioral Health Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Behavioral; Trier Social Stress Test
Experimental: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gene expression via RNAseq	Gene expression over 5 hours in response to stress or a no-stress condition

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1R21AG055621-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No