CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
Effects of dark chocolatebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00099476
NCT00099476Phase 1Completed

Effects of Cocoa Consumption on Insulin Sensitivity and Capillary Recruitment in Subjects With Essential Hypertension

National Center for Complementary and Integrative Health (NCCIH)·interventional·Posted Dec 15, 2004·Updated Jul 2, 2017

In Brief

A Phase 1 clinical trial evaluating Effects of dark chocolate for Hypertension. Completed, across 1 site.

Detailed 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, usually in the early afternoon. For the test, the subject lies in a bed or reclines in a chair. A needle is placed in a vein in each arm - one for collecting blood samples and the other for infusing glucose, insulin, and a potassium solution. Blood glucose and insulin levels are measured frequently during the test and the rate of the glucose infusion is adjusted to keep blood glucose at the baseline (fasting) level. Blood samples are tested for blood count, electrolytes, liver function...

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 15, 2004
Enrollment StartDec 10, 2004
Study CompletionApr 16, 2009
TodayJul 2, 2026
Posted 21.5 years ago

Interventions

Effects of dark chocolatebehavioral