N/A
N=72
Biological Response to Brief Psychological Challenge
Acute Inflammatory Response to Psychological Stress
Bottom Line
View on ClinicalTrials.gov: NCT04078035 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Cell-free Mitochondrial DNA — 165.79; 405.56; 175.45; 164.45 Copies per uL — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Socio-evaluative speech task (Behavioral); Control, Quiet Rest (Behavioral)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cell-free Mitochondrial DNA |
165.79; 405.56; 175.45; 164.45; 414.74; 296.62 | 0.86 |
| PRIMARY Interleukin-6 |
1.52; 1.40; 1.76; 1.58; 1.61; 1.52 | 0.74 |
| PRIMARY Tumor Necrosis Factor-alpha |
5.92; 6.10; 6.62; 6.81; 6.59; 6.28 | 0.52 |
| SECONDARY Heart Rate |
65.60; 66.76; 79.27; 66.36; 71.37; 67.43 | <.001 sig |
| SECONDARY Systolic Blood Pressure |
111.18; 109.43; 120.29; 110.70; 120.02; 109.38 | <.001 sig |
| SECONDARY Diastolic Blood Pressure |
67.69; 65.74; 72.00; 66.02; 72.65; 65.17 | <.001 sig |
| SECONDARY Cortisol |
1.50; 1.48; 1.46; 1.30; 1.57; 1.30 | 0.005 sig |
| SECONDARY Epinephrine |
50.56; 48.62; 54.01; 47.46; 49.81; 52.48 | 0.92 |
| SECONDARY Norepinephrine |
522.86; 480.48; 540.39; 485.44; 526.93; 484.38 | 0.04 sig |
| SECONDARY Heart Rate Variability |
6.50; 6.58; 5.94; 6.50; 6.18; 6.37 | 0.002 sig |
| SECONDARY Fatigue |
4.76; 5.47; 2.59; 5.36; 5.79; 6.48 | 0.008 sig |
| SECONDARY Anger |
0.30; 0.08; 0.70; 0.20; 0.49; 0.16 | 0.83 |
| SECONDARY Anxious Mood |
1.44; 1.35; 3.21; 0.93; 1.56; 1.24 | 0.03 sig |
| SECONDARY Depressed Mood |
0.32; 0.23; 0.46; 0.27; 0.64; 0.29 | 0.51 |
| SECONDARY Vigor |
1.84; 1.65; 3.19; 1.54; 1.39; 1.03 | 0.04 sig |
| SECONDARY Wellbeing |
4.25; 4.10; 3.56; 3.93; 3.61; 3.81 | 0.49 |
| SECONDARY Calm Mood |
9.09; 9.38; 5.87; 8.83; 7.59; 8.29 | 0.002 sig |
Summary
The investigators plan to conduct a crossover experimental trial examining physiological responses to a socio-evaluative speech task under laboratory conditions. Participants will attend two laboratory sessions. At one session participants will take part in a brief laboratory stress task and at the other participants will rest for the same period. Measures of cardiovascular response will be assessed at both sessions. In addition, blood will be drawn at multiple time points across a 125 minute period to assess changes in circulating levels of cortisol, catecholamines, markers of inflammation and cell free mitochondrial DNA in response to the task. The investigators expect that the stress task will induce a specific increase in ccf-mtDNA, which will statistically mediate subsequent peak circulating Interleukin-6 and Tumor Necrosis Factor-α levels. In secondary analyses, the investigators will examine whether stress-induced increases in circulating cortisol, epinephrine, and norepinephrine levels correlate with increases in ccf-mtDNA. These studies will establish the kinetics and magnitude of psychological stress-induced ccf-mtDNA release, the association with early stress mediators, and whether ccf-mtDNA mediates the inflammatory response to acute stress in humans.
Eligibility Criteria
Inclusion Criteria
- Generally healthy
- Non-smokers/illicit drug users
- Blood pressure below 140/90
- Weight > 110 lbs
- BMI 140/90 mmHg at baseline testing.
- Weight < 110 lbs
- BMI equal to or greater than 30
- Report currently taking glucocorticoid, anti-inflammatory, anti-retroviral, immunosuppressant, insulin, antiarrhythmic, antihypertensive, oral hypoglycemic, antidepressant, benzodiazepine or prescription weight loss medications or other medications known to influence the immune, autonomic or neuroendocrine systems.
- For women - Post-menopausal or irregular menstrual cycles over the past 12 months. Report current pregnancy or lactation.
- Current smokers (defined as having smoked a cigarette in the previous 3 months).
- Current illicit drug use (defined as reported use of illicit drugs such as marijuana, cocaine or heroin in the previous 3 months).
- Not fluent in English (have used English in everyday speaking and reading for at least 10 years)
- Unable or unwilling to give informed consent
- Unwilling to abstain from alcohol and vigorous exercise for 24 hours, from food and drinks (other than water) for 3 hours and from non-prescription medications (other than oral contraception) for 2 days prior to testing.
Data sourced from ClinicalTrials.gov (NCT04078035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.