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NCT00538083 · ClinicalTrials.gov registry record · Phase 1

Cocoa and Endothelial Function in Adults With Elevated BMI

A Phase 1 study of Cardioprotection, sponsored by Griffin Hospital.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target
1
Study location

NCT00538083: Completed Phase 1 study of Cardioprotection, sponsored by Griffin Hospital.

NCT00538083 is a Phase 1 study of Cardioprotection that has completed, run by Griffin Hospital. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00538083, a Phase 1 study of Cardioprotection, has completed, sponsored by Griffin Hospital.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target
1
Study location

Study Summary

Cardiovascular disease is the leading cause of death in the United States. Studies have shown that obesity is an important risk factor for development of cardiovascular disease. Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of cardiovascular disease. Recent research findings indicate that consumption of cocoa exerts cardioprotective effects, which include increasing HDL levels, reduction in systolic BP, inhibition of platelet aggregation/activity and activation of endothelial nitric oxide synthase. Proposed is a randomized controlled trial consisting of 4 phases designed to examine the dose-response, and the acute and sustained effects of cocoa consumption on endothelial function as a marker of cardiovascular disease risk in 45 otherwise healthy adults with a BMI 25-35kg/m2.

Conditions Studied

Interventions

  • OTHER Chocolate

Study Locations (1)

Connecticut

  • Griffin Hospital - Derby

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2005-08
Est. Completion 2006-05
Phase Phase 1
Griffin Hospital

22 total trials

What the finished NCT00538083 record still lists

NCT00538083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).

The record links to 1 condition, with Cardioprotection appearing as the primary indexed condition, and to 1 intervention - of which Chocolate is the first listed.

NCT00538083 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT00538083 about?

NCT00538083 is a clinical study titled "Cocoa and Endothelial Function in Adults With Elevated BMI". Cardiovascular disease is the leading cause of death in the United States. Studies have shown that obesity is an important risk factor for development of cardiovascular disease. Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of cardiovascular disease. Recent resear...

What is the current status of trial NCT00538083?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2005-08. Estimated completion is 2006-05.

What conditions does trial NCT00538083 study?

This clinical trial studies the following conditions: Cardioprotection.

What interventions are being tested in trial NCT00538083?

The interventions under investigation include: Chocolate (OTHER).

Who is sponsoring clinical trial NCT00538083?

This trial is sponsored by Griffin Hospital, which has 22 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00538083 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00538083's enrollment target sits among peer trials

45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00538083, the US trial registry maintained by the National Library of Medicine. NCT00538083 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.