VasodilationEarly Phase 1NCT04001647
Targeting ER Stress in Vascular Dysfunction
A Early Phase 1 study testing Acetylcholine, Sodium Nitroprusside and Ascorbic Acid in people with Vasodilation and Arterial Stiffness, run by Colorado State University at 1 site in United States.
Trial summary
Aging and obesity are both risk factors for cardiovascular disease (CVD). One process that links both of these conditions to CVD is vascular dysfunction. Data from animal studies indicate that endoplasmic reticulum (ER) stress may play an important role in the development of endothelial dysfunction in aging and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasodilation, Arterial Stiffness
- What is being tested?
- Acetylcholine, Sodium Nitroprusside and Ascorbic Acid
- 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 16 Aug 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young, healthy weight adults (age: 18-35; BMI 18.5-24.9 kg/m2)
- Young, obese adults (age: 18-35; BMI 30- 39.9 kg/m2)
- Older, healthy weight adults (age: 60-80; 18.5-24.9 kg/m2)
- Older, obese adults (age: 60-80; 30-39.9 kg/m2)
Who cannot join
- blood pressure >140/90 mmHg
- triglycerides >500 mg/dL or LDL cholesterol >190 mg/dL
- current smoking or history of smoking in the last 12 months
- diagnosed chronic disease including cancer, cardiovascular, diabetes, kidney, liver, and pancreatic disease
- weight change >3 kg in the past 3 months or actively trying to lose weight
- >12 alcoholic drinks/week
- hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: Targeting Endoplasmic Reticulum Stress in Aging- and Obesity-Induced Vascular Dysfunction
Aging and obesity are both risk factors for cardiovascular disease (CVD). One process that links both of these conditions to CVD is vascular dysfunction. Data from animal studies indicate that endoplasmic reticulum (ER) stress may play an important role in the development of endothelial dysfunction in aging and obesity. Therefore, the goal of this study is to investigate the relative contributions of aging and obesity on vascular dysfunction and ER stress. Additionally, this study will determine if taking an oral supplement for 8 weeks will improve vascular dysfunction and ER stress. Results from this study have the potential to identify a safe treatment option for improving vascular function in aging and obese populations.
Read the detailed description
Aging is the primary risk factor for cardiovascular disease (CVD). One critical process that links aging to CVD is the development of vascular dysfunction, characterized by endothelial dysfunction and arterial stiffness. Both endothelial dysfunction and arterial stiffness predict cardiovascular events in older individuals. Aging often coincides with obesity, another independent risk factor for CVD. Although vascular function is well characterized in both aging and obesity, it's unclear how these two conditions interact to modulate vascular function, and whether the combination of aging and obesity has additive or compounding effects on endothelial dysfunction and arterial stiffness.
Currently, it is unknown whether vascular dysfunction is driven by the same underlying cellular mechanisms in aging and obesity. Accumulating data in experimental animals suggest that ER stress may be an important factor in aging- and obesity-related vascular dysfunction. Additionally, middle-aged and older obese adults with endothelial dysfunction display evidence of ER stress within biopsied endothelial cells. In light of these data, the overall goal of this proposal is to test the hypothesis that ER stress is associated with human vascular dysfunction in the settings of aging and obesity, and to determine the efficacy of the chemical chaperone tauroursodeoxycholic acid (TUDCA), an established inhibitor of ER stress, to reduce endothelial cell ER stress and improve vascular function in these at-risk individuals. Results from this study have the potential to identify a novel, safe, and clinically relevant intervention strategy for the treatment of vascular dysfunction in an aging population at high-risk for the development of CVD.
- Conditions
- Vasodilation, Arterial Stiffness
- Being tested
- Acetylcholine, Sodium Nitroprusside, Ascorbic Acid
- Keywords
- ER stress, Unfolded protein response, Vascular function, Aging, Obesity, TUDCA
- Medical subject headings
- Aneurysm, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcholineDrug
Also called ACh
Endothelium-dependent vasodilation will be determined via graded intra-arterial infusions of acetylcholine (ACh). Doses of 1, 4, 8, and 16 μg/100ml forearm volume/min will be infused in the brachial artery for 3 minutes each.
Sodium NitroprussideDrug
Also called SNP
Endothelium-independent vasodilation will be determined via graded intra-arterial infusions of sodium nitroprusside (SNP). Doses of 0.25, 0.5, 1, and 2 μg/100ml forearm volume/min will be infused in the brachial artery for 3 minutes each.
Ascorbic AcidDrug
Also called AA, Vitamin C
The influence of oxidative stress on arterial stiffness and vasodilation will be assessed by using intravenous ascorbic acid (AA). A single supra-physiological dose of 0.06 g/kg fat-free mass (FFM) will be infused over 20 min followed by a drip infusion of 0.02 g/kg FFM administered over 60 min.
| Study group | Role | What they receive |
|---|---|---|
| TUDCA | Experimental | Young and older healthy weight and obese participants will visit the lab for assessment of vascular function prior to the intervention. Aortic stiffness will be evaluated non-invasively using carotid-femoral pulse-wave velocity. A physician will place a catheter in the brachial artery for endothelial cell biopsies and local vasodilator infusions. A venous catheter will also be placed for the systemic ascorbic acid infusion. Aortic stiffness measures and vascular responses to vasodilator infusions will be performed before and after the ascorbic acid infusion. Following the completion of the vascular assessments, participants will receive 1750 mg/day of the dietary supplement tauroursodeoxycholic acid (TUDCA) for 8 weeks. Participants will return to the lab after the 8 week intervention and the vascular assessments described above will be repeated. Receives: Drug: Acetylcholine; Drug: Sodium Nitroprusside; Drug: Ascorbic Acid |
| Placebo | Placebo comparator | Older obese participants will visit the lab for assessment of vascular function prior to the intervention. Aortic stiffness will be evaluated non-invasively using carotid-femoral pulse-wave velocity. A physician will place a catheter in the brachial artery for endothelial cell biopsies and local vasodilator infusions. A venous catheter will also be placed for the systemic ascorbic acid infusion. Aortic stiffness measures and vascular responses to vasodilator infusions will be performed before and after the ascorbic acid infusion. Following the completion of the vascular assessments, participants will receive oral capsules containing a placebo treatment for 8 weeks. Participants will return to the lab after the 8 week intervention and the vascular assessments described above will be repeated. Receives: Drug: Acetylcholine; Drug: Sodium Nitroprusside; Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent vasodilation
Blood flow response to increasing doses of acetycholine
Measured: Change in baseline vasodilation at 8 weeks
Endothelium-independent vasodilation
Blood flow response to increasing doses of sodium nitroprusside
Measured: Change in baseline vasodilation at 8 weeks
Aortic stiffness
Carotid-femoral pulse-wave velocity
Measured: Change in baseline pulse-wave velocity at 8 weeks
Endothelial cell ER stress marker ATF6
Protein expression of activating transcription factor 6 (ATF6)
Measured: Change in baseline endothelial ATF6 at 8 weeks
Endothelial cell ER stress marker PERK
Protein expression of RNA-dependent protein kinase- like ER eukaryotic initiation factor-2α kinase (PERK)
Measured: Change in baseline endothelial PERK at 8 weeks
Endothelial cell ER stress marker IRE1α
Protein expression of inositol-requiring ER-to-nucleus signaling protein 1(IRE1α)
Measured: Change in baseline endothelial IRE1α at 8 weeks
Endothelial cell ER stress marker CHOP
Protein expression of CCAAT-enhancer-binding protein homologous protein (CHOP)
Measured: Change in baseline endothelial CHOP at 8 weeks
Endothelial cell ER stress marker GRP78
Protein expression of glucose-regulated protein 78 (GRP78)
Measured: Change in baseline endothelial GRP78 at 8 weeks
Endothelial cell ER stress marker GADD34
Protein expression of growth arrest and DNA damage-inducible 34 (GADD34)
Measured: Change in baseline endothelial GADD34 at 8 weeks
Endothelial cell oxidative stress marker p47phox
Protein expression of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase subunit p47phox
Measured: Change in baseline endothelial p47phox at 8 weeks
Endothelial cell oxidative stress marker NT
Protein expression of nitrotyrosine (NT)
Measured: Change in baseline endothelial NT at 8 weeks
Endothelial cell oxidative stress marker MnSOD
Protein expression of manganese superoxide dismutase (MnSOD)
Measured: Change in baseline endothelial MnSOD at 8 weeks
Endothelial cell oxidative stress marker CuZnSOD
Protein expression of copper-zinc SOD (CuZnSOD)
Measured: Change in baseline endothelial CuZnSOD at 8 weeks
Endothelial cell inflammatory marker p65
Protein expression of nuclear factor kappa B phosphorylated p65 subunit
Measured: Change in baseline endothelial p65 at 8 weeks
Endothelial cell inflammatory marker IκBα
Protein expression of phosphorylated inhibitor of kappa B (IκBα)
Measured: Change in baseline endothelial IκBα at 8 weeks
Endothelial cell inflammatory marker TNFα
Protein expression of tumor necrosis factor-alpha (TNFα)
Measured: Change in baseline endothelial TNFα at 8 weeks
Endothelial cell inflammatory marker IL-6
Protein expression of interleukin-6 (IL-6)
Measured: Change in baseline endothelial IL-6 at 8 weeks
Secondary outcomes (10)
Circulating glucose
Blood glucose
Measured: Change in baseline blood glucose at 8 weeks
Circulating insulin
Blood levels of insulin
Measured: Change in baseline insulin at 8 weeks
Circulating cholesterol
Blood levels of total cholesterol, LDL cholesterol, and HDL cholesterol
Measured: Change in baseline total cholesterol, LDL cholesterol, and HDL cholesterol at 8 weeks
Circulating triglycerides
Blood levels of triglycerides
Measured: Change in baseline triglycerides at 8 weeks
Circulating CRP
Blood levels of C-reactive protein (CRP)
Measured: Change in baseline CRP at 8 weeks
Circulating IL-6
Blood levels of interleukin (IL)-6
Measured: Change in baseline IL-6 at 8 weeks
Circulating IL-18
Blood levels of interleukin (IL)-18
Measured: Change in baseline IL-18 at 8 weeks
Circulating IL-10
Blood levels of interleukin (IL)-10
Measured: Change in baseline IL-10 at 8 weeks
Circulating IL-1β
Blood levels of interleukin (IL)-1 beta (β)
Measured: Change in baseline IL-1β at 8 weeks
Circulating TNFα
Blood levels of tumor necrosis factor-alpha (TNFα)
Measured: Change in baseline TNFα at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jun 2019
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Why it stopped: IRB approval has been withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasodilationStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants from each group (young healthy weight, young obese, older healthy weight, older obese) will be studied before and after 8 weeks of tauroursodeoxycholic acid (TUDCA) treatment. Additional older obese participants will be studied before and after 8 weeks of a placebo treatment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Dinenno, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001647
- Sponsor's protocol ID
- TUDCA and Vascular Health
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2019
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Endoplasmic Reticulum Stress in Aging- and Obesity-Induced Vascular Dysfunction
- ClinicalTrials.gov ID
- NCT04001647
- Acronym / sponsor ID
- TUDCA and Vascular Health
- Conditions
- Vasodilation, Arterial Stiffness
- Keywords
- ER stress, Unfolded protein response, Vascular function, Aging, Obesity, TUDCA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB approval has been withdrawn
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 28 Jun 2019 (actual)
- 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.
Aging and obesity are both risk factors for cardiovascular disease (CVD). One process that links both of these conditions to CVD is vascular dysfunction. Data from animal studies indicate that endoplasmic reticulum (ER) stress may play an important role in the development of endothelial dysfunction in aging and obesity. Therefore, the goal of this study is to investigate the relative contributions of aging and obesity on vascular dysfunction and ER stress. Additionally, this study will determine if taking an oral supplement for 8 weeks will improve vascular dysfunction and ER stress. Results from this study have the potential to identify a safe treatment option for improving vascular function in aging and obese populations.
Detailed description
Aging is the primary risk factor for cardiovascular disease (CVD). One critical process that links aging to CVD is the development of vascular dysfunction, characterized by endothelial dysfunction and arterial stiffness. Both endothelial dysfunction and arterial stiffness predict cardiovascular events in older individuals. Aging often coincides with obesity, another independent risk factor for CVD. Although vascular function is well characterized in both aging and obesity, it's unclear how these two conditions interact to modulate vascular function, and whether the combination of aging and obesity has additive or compounding effects on endothelial dysfunction and arterial stiffness.
Currently, it is unknown whether vascular dysfunction is driven by the same underlying cellular mechanisms in aging and obesity. Accumulating data in experimental animals suggest that ER stress may be an important factor in aging- and obesity-related vascular dysfunction. Additionally, middle-aged and older obese adults with endothelial dysfunction display evidence of ER stress within biopsied endothelial cells. In light of these data, the overall goal of this proposal is to test the hypothesis that ER stress is associated with human vascular dysfunction in the settings of aging and obesity, and to determine the efficacy of the chemical chaperone tauroursodeoxycholic acid (TUDCA), an established inhibitor of ER stress, to reduce endothelial cell ER stress and improve vascular function in these at-risk individuals. Results from this study have the potential to identify a novel, safe, and clinically relevant intervention strategy for the treatment of vascular dysfunction in an aging population at high-risk for the development of CVD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants from each group (young healthy weight, young obese, older healthy weight, older obese) will be studied before and after 8 weeks of tauroursodeoxycholic acid (TUDCA) treatment. Additional older obese participants will be studied before and after 8 weeks of a placebo treatment.
| Arm | Type | Receives |
|---|---|---|
| TUDCA | Experimental | Drug: Acetylcholine, Drug: Sodium Nitroprusside, Drug: Ascorbic AcidYoung and older healthy weight and obese participants will visit the lab for assessment of vascular function prior to the intervention. Aortic stiffness will be evaluated non-invasively using carotid-femoral pulse-wave velocity. A physician will place a catheter in the brachial artery for endothelial cell biopsies and local vasodilator infusions. A venous catheter will also be placed for the systemic ascorbic acid infusion. Aortic stiffness measures and vascular responses to vasodilator infusions will be performed before and after the ascorbic acid infusion. Following the completion of the vascular assessments, participants will receive 1750 mg/day of the dietary supplement tauroursodeoxycholic acid (TUDCA) for 8 weeks. Participants will return to the lab after the 8 week intervention and the vascular assessments described above will be repeated. |
| Placebo | Placebo comparator | Drug: Acetylcholine, Drug: Sodium Nitroprusside, Drug: Ascorbic AcidOlder obese participants will visit the lab for assessment of vascular function prior to the intervention. Aortic stiffness will be evaluated non-invasively using carotid-femoral pulse-wave velocity. A physician will place a catheter in the brachial artery for endothelial cell biopsies and local vasodilator infusions. A venous catheter will also be placed for the systemic ascorbic acid infusion. Aortic stiffness measures and vascular responses to vasodilator infusions will be performed before and after the ascorbic acid infusion. Following the completion of the vascular assessments, participants will receive oral capsules containing a placebo treatment for 8 weeks. Participants will return to the lab after the 8 week intervention and the vascular assessments described above will be repeated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Young, healthy weight adults (age: 18-35; BMI 18.5-24.9 kg/m2)
- Young, obese adults (age: 18-35; BMI 30- 39.9 kg/m2)
- Older, healthy weight adults (age: 60-80; 18.5-24.9 kg/m2)
- Older, obese adults (age: 60-80; 30-39.9 kg/m2)
Key exclusion criteria (7 listed)
- blood pressure >140/90 mmHg
- triglycerides >500 mg/dL or LDL cholesterol >190 mg/dL
- current smoking or history of smoking in the last 12 months
- diagnosed chronic disease including cancer, cardiovascular, diabetes, kidney, liver, and pancreatic disease
- weight change >3 kg in the past 3 months or actively trying to lose weight
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 |
|---|---|---|
| AcetylcholineAlso: AChEndothelium-dependent vasodilation will be determined via graded intra-arterial infusions of acetylcholine (ACh). Doses of 1, 4, 8, and 16 μg/100ml forearm volume/min will be infused in the brachial artery for 3 minutes each. | Drug | Placebo, TUDCA |
| Sodium NitroprussideAlso: SNPEndothelium-independent vasodilation will be determined via graded intra-arterial infusions of sodium nitroprusside (SNP). Doses of 0.25, 0.5, 1, and 2 μg/100ml forearm volume/min will be infused in the brachial artery for 3 minutes each. | Drug | Placebo, TUDCA |
| Ascorbic AcidAlso: AA, Vitamin CThe influence of oxidative stress on arterial stiffness and vasodilation will be assessed by using intravenous ascorbic acid (AA). A single supra-physiological dose of 0.06 g/kg fat-free mass (FFM) will be infused over 20 min followed by a drip infusion of 0.02 g/kg FFM administered over 60 min. | Drug | Placebo, TUDCA |
Primary outcome
Endothelium-dependent vasodilation
Time frame: Change in baseline vasodilation at 8 weeks
Blood flow response to increasing doses of acetycholine
Endothelium-independent vasodilation
Time frame: Change in baseline vasodilation at 8 weeks
Blood flow response to increasing doses of sodium nitroprusside
Aortic stiffness
Time frame: Change in baseline pulse-wave velocity at 8 weeks
Carotid-femoral pulse-wave velocity
Endothelial cell ER stress marker ATF6
Time frame: Change in baseline endothelial ATF6 at 8 weeks
Protein expression of activating transcription factor 6 (ATF6)
Endothelial cell ER stress marker PERK
Time frame: Change in baseline endothelial PERK at 8 weeks
Protein expression of RNA-dependent protein kinase- like ER eukaryotic initiation factor-2α kinase (PERK)
Endothelial cell ER stress marker IRE1α
Time frame: Change in baseline endothelial IRE1α at 8 weeks
Protein expression of inositol-requiring ER-to-nucleus signaling protein 1(IRE1α)
Endothelial cell ER stress marker CHOP
Time frame: Change in baseline endothelial CHOP at 8 weeks
Protein expression of CCAAT-enhancer-binding protein homologous protein (CHOP)
Endothelial cell ER stress marker GRP78
Time frame: Change in baseline endothelial GRP78 at 8 weeks
Protein expression of glucose-regulated protein 78 (GRP78)
Endothelial cell ER stress marker GADD34
Time frame: Change in baseline endothelial GADD34 at 8 weeks
Protein expression of growth arrest and DNA damage-inducible 34 (GADD34)
Endothelial cell oxidative stress marker p47phox
Time frame: Change in baseline endothelial p47phox at 8 weeks
Protein expression of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase subunit p47phox
Endothelial cell oxidative stress marker NT
Time frame: Change in baseline endothelial NT at 8 weeks
Protein expression of nitrotyrosine (NT)
Endothelial cell oxidative stress marker MnSOD
Time frame: Change in baseline endothelial MnSOD at 8 weeks
Protein expression of manganese superoxide dismutase (MnSOD)
Endothelial cell oxidative stress marker CuZnSOD
Time frame: Change in baseline endothelial CuZnSOD at 8 weeks
Protein expression of copper-zinc SOD (CuZnSOD)
Endothelial cell inflammatory marker p65
Time frame: Change in baseline endothelial p65 at 8 weeks
Protein expression of nuclear factor kappa B phosphorylated p65 subunit
Endothelial cell inflammatory marker IκBα
Time frame: Change in baseline endothelial IκBα at 8 weeks
Protein expression of phosphorylated inhibitor of kappa B (IκBα)
Endothelial cell inflammatory marker TNFα
Time frame: Change in baseline endothelial TNFα at 8 weeks
Protein expression of tumor necrosis factor-alpha (TNFα)
Endothelial cell inflammatory marker IL-6
Time frame: Change in baseline endothelial IL-6 at 8 weeks
Protein expression of interleukin-6 (IL-6)
10 secondary outcomes
Circulating glucose
Time frame: Change in baseline blood glucose at 8 weeks
Circulating insulin
Time frame: Change in baseline insulin at 8 weeks
Circulating cholesterol
Time frame: Change in baseline total cholesterol, LDL cholesterol, and HDL cholesterol at 8 weeks
Circulating triglycerides
Time frame: Change in baseline triglycerides at 8 weeks
Circulating CRP
Time frame: Change in baseline CRP at 8 weeks
Circulating IL-6
Time frame: Change in baseline IL-6 at 8 weeks
Circulating IL-18
Time frame: Change in baseline IL-18 at 8 weeks
Circulating IL-10
Time frame: Change in baseline IL-10 at 8 weeks
Circulating IL-1β
Time frame: Change in baseline IL-1β at 8 weeks
Circulating TNFα
Time frame: Change in baseline TNFα at 8 weeks
Results and safety
The study was stopped early (reason given: IRB approval has been withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Vasodilation
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
RecruitingEarly Phase 1
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia
Aging, Menopause
RecruitingPhase 2
The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults
Frailty, Mild Cognitive Impairment
RecruitingEarly Phase 1
Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
Obesity, Vasodilation
Recruiting
Reducing Blood Pressure in Mid-life Adult Binge Drinkers
Alcohol Drinking, Binge Drinking
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.
Frank Dinenno, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acetylcholine, Sodium Nitroprusside and Ascorbic Acid in people with Vasodilation and Arterial Stiffness, run by Colorado State 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IRB approval has been withdrawn). Results are not available in the source record.
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?
Endothelium-dependent vasodilation (time frame: Change in baseline vasodilation at 8 weeks). The study lists 17 primary outcomes in all. 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 8 Apr 2025.