Cardiovascular DiseaseNO-StressNCT02115724
Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)
A study testing Antioxidant cocktail, Biopsy and NMD; 0.4mg sub-lingual nitroglycerin spray in people with Cardiovascular Disease, run by Augusta University at 1 site in United States.
Trial summary
Cardiovascular disease is the leading cause of death in the United States. Other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. This study will look at the effect of early life stressors on your cardiovascular health. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Antioxidant cocktail, Biopsy and NMD; 0.4mg sub-lingual nitroglycerin spray
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- documented childhood SES
- men and premenopausal women ages 18-40
- lean/overweight/or obese with BMI< or equal to 39kg/m2
Who cannot join
- cardiovascular, renal, pulmonary, hepatic, cerebral, or metabolic,disease
- use medications that affect vascular tone
- post menopausal women
- have class 3 obesity or BMI over 40
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Prevention Institute , Georgia Regents University
Augusta, Georgia, 30912
About this study
Official title: Effect of Low Childhood Socioeconomic Status (SES) on Adult Endothelial Function and Nitric Oxide Bioavailability in Vivo and ex Vivo
Cardiovascular disease is the leading cause of death in the United States. Other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. This study will look at the effect of early life stressors on your cardiovascular health.
Read the detailed description
This study will have two parts involved to investigate the role that childhood SES status has on cardiovascular health.
Part one: Subjects will give a blood sample which will be processed and analyzed. Flow mediated dilation (FMD) and Pulse wave velocity (PWV/PWA) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg of Vitamin C, 600 IU of Vitamin E, and 600 mg of alpha-lipoic acid) or placebo on two days separated by at least 72 hours. Nitroglycerin mediated dilation (NMD, 0.4mg sub-lingual nitroglycerin spray), will be assessed at baseline.
Part two: Subjects, if interested will undergo a subcutaneous gluteal/hip fat biopsy. Micro vessels will be isolated from the adipose tissue and analyzed by pressurized myography for endothelial function and nitric oxide bioavailability.
- Conditions
- Cardiovascular Disease
- Being tested
- Antioxidant cocktail, Biopsy, Placebo, NMD; 0.4mg sub-lingual nitroglycerin spray
- Keywords
- Low childhood SES, Early Life Stress, Endothelial function, Flow mediated dilation, Cardiovascular disease, Subcutaneous adipose arterioles
- Medical subject headings
- Cardiovascular Diseases, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant cocktailDietary supplement
Also called Vitamin C, Vitamin E, Alpha Lipoic Acid
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
BiopsyOther
Under sterile conditions, a small incision (¼ - ½ inch) by the study doctor will be made and the piece of fat will be taken out. Fat tissue was chosen for this study because it is a big source of small blood vessels which we are studying
PlaceboOther
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
NMD; 0.4mg sub-lingual nitroglycerin sprayDrug
Also called Generic name: Nitrolingual, Manufacturer: Arbor Pharmaceuticals
Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant Cocktail | Experimental | Following an overnight fast, blood samples, flow-mediated dilation, and nitroglycerin mediated dilation (NMD; 0.4mg sub-lingual nitroglycerin spray) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg Vitamin C, 600 IU vitamin E, 600 mg Alpha Lipoic Acid) or placebo on two days separated by at least 72 hours. Receives: Dietary Supplement: Antioxidant cocktail; Other: Placebo; Drug: NMD; 0.4mg sub-lingual nitroglycerin spray |
| Biopsy | Other | Following an overnight fast, a subcutaneous gluteal/hip fat biopsy sample will be obtained from each subject under local anesthesia, with adipose tissue (~2x1.5x1.5cm) to be harvested and placed immediately in physiological saline solution (PSS): Small arteries, 100 to 150 um in diameter, will be dissected from the fat under a dissecting microscope, transferred to an arteriographic bath chamber, and cannulated for pressurized myography. Receives: Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Change in Flow mediated dilation
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Measured: Change from baseline (2 hours)
Secondary outcomes (3)
Acute Change in Biomarkers of oxidative stress
Nitrite/nitrate, antioxidant capacity, and 8-isoprostane at baseline and 2 hours following acute antioxidant treatment
Measured: Change from baseline (2 hours)
Acute Change in Arterial Stiffness
Pulse wave velocity will be determined at baseline and 2 hours following acute antioxidant treatment
Measured: Change from baseline (2 hours)
Acute change in Flow mediated dilation
Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ryan Harris, Augusta University
- Investigators
- Ryan Harris, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115724
- Sponsor's protocol ID
- NO-Stress Pro00001887
- Other IDs
- 5P01HL069999
- Acronym
- NO-Stress
- Status last verified
- Jan 2025
- First submitted
- 28 Mar 2014
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Childhood Socioeconomic Status (SES) on Adult Endothelial Function and Nitric Oxide Bioavailability in Vivo and ex Vivo
- ClinicalTrials.gov ID
- NCT02115724
- Acronym / sponsor ID
- NO-Stress / NO-Stress Pro00001887
- Conditions
- Cardiovascular Disease
- Keywords
- Low childhood SES, Early Life Stress, Endothelial function, Flow mediated dilation, Cardiovascular disease, Subcutaneous adipose arterioles
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2014
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease is the leading cause of death in the United States. Other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. This study will look at the effect of early life stressors on your cardiovascular health.
Detailed description
This study will have two parts involved to investigate the role that childhood SES status has on cardiovascular health.
Part one: Subjects will give a blood sample which will be processed and analyzed. Flow mediated dilation (FMD) and Pulse wave velocity (PWV/PWA) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg of Vitamin C, 600 IU of Vitamin E, and 600 mg of alpha-lipoic acid) or placebo on two days separated by at least 72 hours. Nitroglycerin mediated dilation (NMD, 0.4mg sub-lingual nitroglycerin spray), will be assessed at baseline.
Part two: Subjects, if interested will undergo a subcutaneous gluteal/hip fat biopsy. Micro vessels will be isolated from the adipose tissue and analyzed by pressurized myography for endothelial function and nitric oxide bioavailability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant Cocktail | Experimental | Dietary Supplement: Antioxidant cocktail, Other: Placebo, Drug: NMD; 0.4mg sub-lingual nitroglycerin sprayFollowing an overnight fast, blood samples, flow-mediated dilation, and nitroglycerin mediated dilation (NMD; 0.4mg sub-lingual nitroglycerin spray) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg Vitamin C, 600 IU vitamin E, 600 mg Alpha Lipoic Acid) or placebo on two days separated by at least 72 hours. |
| Biopsy | Other | Other: BiopsyFollowing an overnight fast, a subcutaneous gluteal/hip fat biopsy sample will be obtained from each subject under local anesthesia, with adipose tissue (~2x1.5x1.5cm) to be harvested and placed immediately in physiological saline solution (PSS): Small arteries, 100 to 150 um in diameter, will be dissected from the fat under a dissecting microscope, transferred to an arteriographic bath chamber, and cannulated for pressurized myography. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- documented childhood SES
- men and premenopausal women ages 18-40
- lean/overweight/or obese with BMI< or equal to 39kg/m2
Key exclusion criteria (4 listed)
- cardiovascular, renal, pulmonary, hepatic, cerebral, or metabolic,disease
- use medications that affect vascular tone
- post menopausal women
- have class 3 obesity or BMI over 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidant cocktailAlso: Vitamin C, Vitamin E, Alpha Lipoic AcidFlow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment | Dietary supplement | Antioxidant Cocktail |
| BiopsyUnder sterile conditions, a small incision (¼ - ½ inch) by the study doctor will be made and the piece of fat will be taken out. Fat tissue was chosen for this study because it is a big source of small blood vessels which we are studying | Other | Biopsy |
| PlaceboFlow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment | Other | Antioxidant Cocktail |
| NMD; 0.4mg sub-lingual nitroglycerin sprayAlso: Generic name: Nitrolingual, Manufacturer: Arbor PharmaceuticalsNitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual. | Drug | Antioxidant Cocktail |
Primary outcome
Acute Change in Flow mediated dilation
Time frame: Change from baseline (2 hours)
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
3 secondary outcomes
Acute Change in Biomarkers of oxidative stress
Time frame: Change from baseline (2 hours)
Acute Change in Arterial Stiffness
Time frame: Change from baseline (2 hours)
Acute change in Flow mediated dilation
Time frame: Immediate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Harris, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidant cocktail, Biopsy and NMD; 0.4mg sub-lingual nitroglycerin spray in people with Cardiovascular Disease, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Change in Flow mediated dilation (time frame: Change from baseline (2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.