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NCT01395277 · ClinicalTrials.gov registry record · NA
Role of Flavanols In Cardiovascular Function in Healthy Aging
A NA study, sponsored by University of Texas at Austin.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01395277: Completed NA study, sponsored by University of Texas at Austin.
NCT01395277 is a NA study that has completed, run by University of Texas at Austin. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01395277, a NA study, has completed, sponsored by University of Texas at Austin.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Groups of naturally occurring compounds called flavonoids are found in foods such as fruits and vegetables, red wine, tea, dark chocolate and cocoa products. Diets rich in flavonoids are associated with decreased risk for cardiovascular disease and major cardiovascular events (i.e. myocardial infarction) and have been shown to improve blood pressure, insulin sensitivity, and vascular function in a variety populations (Type II diabetes, elderly, smokers, etc.). The presumed beneficial effects of these compounds are thought to act through their inherent ability to scavenge free radicals. Specifically flavonoids scavenge superoxide anions which are free radicals that react with nitric oxide (NO) to produce peroxynitrite. The formation of peroxynitrite ultimately reduces the bioavailability of NO which is essential for vasodilation and thus vascular health and function. Normal aging is associated with impaired endothelial function, which presumably is due to less than optimal levels of NO bioavailability. Therefore, interventions that can increase NO bioavailability would be expected to improve microvascular function and vascular health in this population. The purpose of this study is to investigate the effects of dietary flavonoid supplementation on the vasodilatory capacity of the cutaneous vasculature, as well as on cerebral vascular reactivity and arterial stiffness in young and old humans. This study will test the hypothesis that acute dietary flavonoid treatment will improve impaired cutaneous vasodilatory capacity, cerebral vasomotor reactivity, and reduce arterial stiffness in older but not young humans.
Primary Outcome
Local heating of the cutaneous vasculature to 42 degree C is commonly used to evoke a maximal skin blood flow response (only at the site of local heating). This response is almost entirely dependent on nitric oxide mediated vasodilation.
Interventions
- DIETARY_SUPPLEMENT High Flavanol first then Low Flavanol
- DIETARY_SUPPLEMENT Low Flavanol first then High Flavanol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-05 |
| Phase | NA |
What the finished NCT01395277 record still lists
NCT01395277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which High Flavanol first then Low Flavanol is the first listed.
NCT01395277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01395277 about?
NCT01395277 is a clinical study titled "Role of Flavanols In Cardiovascular Function in Healthy Aging". Groups of naturally occurring compounds called flavonoids are found in foods such as fruits and vegetables, red wine, tea, dark chocolate and cocoa products. Diets rich in flavonoids are associated with decreased risk for cardiovascular disease and major cardiovascular events (i.e. myocardial infarc...
What is the current status of trial NCT01395277?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2011-09. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01395277?
The interventions under investigation include: High Flavanol first then Low Flavanol (DIETARY_SUPPLEMENT), Low Flavanol first then High Flavanol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01395277?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01395277's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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