Brief Stresses Experimental Study
- Conditions
- DNA DamagePsychological Stress
- Interventions
- Registration Number
- NCT03893617
- Lead Sponsor
- Dana Bovbjerg
- Brief Summary
The goal of this study is to examine the impact of psychological stress on DNA integrity by conducting an experiment under controlled conditions with healthy volunteers to directly test the extent to which acute stress increases DNA damage, while simultaneously testing the blocking effects of pre-treatment with propranolol, and exploring key hypothesized mediators and moderators of the severity of the DNA damage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 239
- Age 20-59
- Weigh at least 110 pounds
- Fasting blood sugar below 150 mg/dL, or random blood sugar below 200 mg/dL
- Thyroid stimulating hormone level between 0.25 mU/L and 6.0 mU/L
- Resting blood pressure below 160/100 mm Hg
- If female, have either regular menstrual periods (21-35 days) or are post-menopausal
- Use of illicit drugs or nicotine-containing products other than cigarettes in the past month
- Current alcohol abuse
- Diagnosed with any of the following: cancer (other than basal cell skin cancer), chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), severe traumatic brain injury, hypertension (high blood pressure), coronary artery disease, congestive heart failure, or other serious heart disease
- Current diabetes, asthma, depression, bipolar disorder, anxiety, or schizophrenia
- If female, pregnancy or breastfeeding within the past 3 months
- If female, taking any medications that prevent monthly menstrual cycles (e.g., birth control shot, IUD, "seasonal" birth control)
- Resting systolic blood pressure of < 90 mm Hg or resting pulse < 50 beats per minute
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propranolol group Acute stress task This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit. Propranolol group No stress task This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit. Placebo group Placebo oral capsule This group will receive a single blinded capsule containing no active medication during their acute stress study visit. Placebo group Acute stress task This group will receive a single blinded capsule containing no active medication during their acute stress study visit. Placebo group No stress task This group will receive a single blinded capsule containing no active medication during their acute stress study visit. Propranolol group Propranolol This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit.
- Primary Outcome Measures
Name Time Method DNA Stress Response Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute acute stress task period Change in percent tail intensity will be measured using the Comet assay of DNA damage in blood samples
- Secondary Outcome Measures
Name Time Method DNA Stress Response (8-OHdG) Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period Change in DNA 8-OHdG levels will be measured in blood samples
DNA Stress Response (γ-H2AX) Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period Change in cellular γ-H2AX levels will be measured in blood samples
Neuroendocrine Stress Response (Norepinephrine (NE)) Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period Change in circulating plasma NE levels will be measured in blood samples
Neuroendocrine Stress Response (Epinephrine (EPI)) Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period Change in circulating plasma EPI levels will be measured in blood samples
Hematological Stress Response Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period Change in the white blood cell populations present in blood samples will be measured through complete blood count with differential analysis and flow cytometry
Cardiovascular Stress Response (Heart rate (HR)) HR will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period Change in HR will be calculated from repeated assessments
Cardiovascular Stress Response (Systolic blood pressure (SBP)) Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period Change in SBP/DBP will be calculated from repeated assessments
Cardiovascular Stress Response (Diastolic blood pressure (DBP)) Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period Change in DBP will be calculated from repeated assessments
Psychological Stress Response (Anxiety Visual Analogue Scale (VAS)) Anxiety VAS will be administered after a 60 minute baseline period and during/after completion of the tasks Change in anxiety levels will be assessed by self-report measure (VAS) on a 0 to 100 scale, where 0 indicates not feeling anxious and 100 indicates feeling highly anxious
Psychological Stress Response (Stress Visual Analogue Scale (VAS)) Stress VAS will be administered after a 60 minute baseline period and during/after completion of the tasks Change in stress levels will be assessed by self-report measure (VAS) on a 0 to 100 scale, where 0 indicates not feeling stressed and 100 indicates feeling highly stressed
Trial Locations
- Locations (1)
UPMC Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States