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Ascorbic Acid for Vasodilation

Q: Does the research encompass those aged 75 and above?

This trial welcomes participants aged 18 to 80, with an additional 1 study for those younger than 18 and 59 studies marketed towards individuals over age 65.

Q: What are the main goals of this research project?

This medical experiment, which will measure its efficacy over a 8 week period, seeks to improve endothelium-independent vasodilation. Secondary aims include measuring blood levels of interleukin (IL)-18 and IL-6 as well as circulating triglycerides.

Q: In what medical scenarios is Ascorbic Acid typically prescribed?

Ascorbic Acid is widely used to address iron deficiency anemia, as well as a variety of other issues such as vitamin A or C deficits and catarrh.

Q: Are there still openings in this research program for participants?

Yes, the records on clinicaltrials.gov affirm that this medical experiment is actively seeking enrollees. It was first announced on June 1st 2019 and most recently updated July 18th 2022. The trial will admit 60 people at a single location.

Q: Do I have the necessary qualifications to partake in this research project?

This medical research requires 60 participants with vasodilation, ranging from 18 to 80 years old. The remaining requirements for eligibility are as follows: Young, healthy adults (18-35 and BMI of 18.5-24.9 kg/m2), young obese individuals (18-35 and BMI 30–39.9 kg/m2), older obese persons (60-80 and BMI 30–39.9 kg) ,and elderly patients who maintain a healthy weight range (60-80 and BMI 18.5–24.9kg/m2).

Q: How many participants are allowed to join this research program?

Affirmative. Data hosted on clinicaltrials.gov verifies that this scientific research, which was initially published on June 1st 2019, is actively recruiting participants. Approximately 60 subjects need to be enrolled from one medical facility.

Phase < 1

Waitlist Available

Led By Frank Dinenno, PhD

Research Sponsored by Colorado State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in baseline tnfα at 8 weeks

Awards & highlights

Study Summary

This trial will investigate if taking an oral supplement for 8 weeks will improve vascular dysfunction and ER stress in aging and obese populations.

Eligible Conditions

Vasodilation
Arterial Stiffness

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in baseline endothelial ire1α at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in baseline endothelial ire1α at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline endothelial ire1α at 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aortic stiffness

Endothelial cell ER stress marker ATF6

Endothelial cell ER stress marker CHOP

+14 more

Secondary outcome measures

Circulating CRP

Circulating IL-10

Circulating IL-18

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TUDCAExperimental Treatment3 Interventions

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.

Group II: PlaceboPlacebo Group3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ascorbic Acid

2017

Completed Phase 4

~2240

Acetylcholine

2013

Completed Phase 2

~220

Sodium Nitroprusside

2018

Completed Phase 1

~220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Colorado State UniversityLead Sponsor

125 Previous Clinical Trials

38,299 Total Patients Enrolled

1 Trials studying Vasodilation

Frank Dinenno, PhDPrincipal Investigator - Colorado State University

Colorado State University

3 Previous Clinical Trials

40 Total Patients Enrolled

1 Trials studying Vasodilation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research encompass those aged 75 and above?

"This trial welcomes participants aged 18 to 80, with an additional 1 study for those younger than 18 and 59 studies marketed towards individuals over age 65."

Answered by AI

What are the main goals of this research project?

"This medical experiment, which will measure its efficacy over a 8 week period, seeks to improve endothelium-independent vasodilation. Secondary aims include measuring blood levels of interleukin (IL)-18 and IL-6 as well as circulating triglycerides."

Answered by AI

In what medical scenarios is Ascorbic Acid typically prescribed?

"Ascorbic Acid is widely used to address iron deficiency anemia, as well as a variety of other issues such as vitamin A or C deficits and catarrh."

Answered by AI

Are there still openings in this research program for participants?

"Yes, the records on clinicaltrials.gov affirm that this medical experiment is actively seeking enrollees. It was first announced on June 1st 2019 and most recently updated July 18th 2022. The trial will admit 60 people at a single location."

Answered by AI

Do I have the necessary qualifications to partake in this research project?

"This medical research requires 60 participants with vasodilation, ranging from 18 to 80 years old. The remaining requirements for eligibility are as follows: Young, healthy adults (18-35 and BMI of 18.5-24.9 kg/m2), young obese individuals (18-35 and BMI 30–39.9 kg/m2), older obese persons (60-80 and BMI 30–39.9 kg) ,and elderly patients who maintain a healthy weight range (60-80 and BMI 18.5–24.9kg/m2)."

Answered by AI

How many participants are allowed to join this research program?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this scientific research, which was initially published on June 1st 2019, is actively recruiting participants. Approximately 60 subjects need to be enrolled from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeting ER Stress in Vascular Dysfunction

Frank Dinenno 2019. "Targeting ER Stress in Vascular Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04001647.