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NCT00099476 · ClinicalTrials.gov registry record · Phase 1
Effects of Dark Chocolate on Insulin Sensitivity in People With High Blood Pressure
A Phase 1 study of Hypertension, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT00099476: Completed Phase 1 study of Hypertension, sponsored by National Center for Complementary and Integrative Health (NCCIH).
NCT00099476 is a Phase 1 study of Hypertension that has completed, run by National Center for Complementary and Integrative Health (NCCIH). The registered enrollment target is 65 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00099476, a Phase 1 study of Hypertension, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine whether dark chocolate affects the way patients with hypertension (high blood pressure) respond to insulin, a hormone secreted by the pancreas that regulates blood glucose (sugar) levels. In many people with hypertension, insulin is not as effective in helping the body use glucose. This is called insulin resistance. Insulin also increases blood flow into muscle by opening inactive blood vessels. Laboratory studies suggest that eating dark chocolate may improve blood pressure. This study will determine whether dark chocolate improves insulin resistance or changes how blood vessels react to insulin in hypertensive people. People between 21 and 65 years of age who have high blood pressure and are not pregnant may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants refrain from eating foods containing chocolate or cocoa for 1 week and then come to the clinic on three separate occasions 3 weeks apart for a glucose clamp test and contrast ultrasound, described below. At the first glucose clamp test, subjects are randomly assigned to drink either a cocoa drink with high anti-oxidant content or one with a very low content of anti-oxidant. Each drink will be taken twice a day for 2 weeks. At the end of the 2 weeks, they return for a second glucose clamp test. At the second test, they stop taking the cocoa drink for 1 week and then start again for another 2 weeks. For this 2-week period, those who were given the high anti-oxidant content cocoa drink the first 2 weeks will take the placebo, very low anti-oxidant drink this time, and those who took the placebo will now have the high anti-oxidant cocoa drink. After this 2 weeks of taking the cocoa drink or placebo, they then take the third and last glucose clamp test. Glucose clamp test: This test measures how the body responds to insulin. Subjects fast the night before each test and do not eat until the test is over,
Conditions Studied
Interventions
- BEHAVIORAL Effects of dark chocolate
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2004-12-10 |
| Est. Completion | 2009-04-16 |
| Phase | Phase 1 |
What the finished NCT00099476 record still lists
NCT00099476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Effects of dark chocolate is the first listed.
NCT00099476 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00099476 about?
NCT00099476 is a clinical study titled "Effects of Dark Chocolate on Insulin Sensitivity in People With High Blood Pressure". This study will examine whether dark chocolate affects the way patients with hypertension (high blood pressure) respond to insulin, a hormone secreted by the pancreas that regulates blood glucose (sugar) levels. In many people with hypertension, insulin is not as effective in helping the body use gl...
What is the current status of trial NCT00099476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2004-12-10. Estimated completion is 2009-04-16.
What conditions does trial NCT00099476 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00099476?
The interventions under investigation include: Effects of dark chocolate (BEHAVIORAL).
Who is sponsoring clinical trial NCT00099476?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00099476 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00099476's enrollment target sits among peer trials
65 341st of 470 higher than 130 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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.
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