Study Title:
Effects of Xocai Antioxidant Supplements on Atherosclerosis Risk Factors
Study Description:
We will perform 2 studies: first, an open-label pilot time-course study and second, an open-label crossover, study of ingestion of Xocai beverage (at two doses), nuggets and bars by healthy human subjects, during which we will test our hypotheses. The hypothesis is that when given to human subjects:
1) Xocai beverage will have rapid onset and offset (over a few weeks) of various favorable effects on lipoproteins, glucose and arterial function.
2) Xocai beverage, nuggets and bars will have dramatic antioxidant effects in human subjects as demonstrated by standard assays of plasma and urine antioxidant status
3)Xocai beverage and nuggets will improve several atherosclerosis risk factors such as:
a) improving lipid and lipoprotein parameters
b) reducing insulin resistance
c) reducing inflammatory risk factors of atherosclerosis
d) improving endothelial and vascular function
|
4) The standard dose of Xocai nuggets and bars will have equivalent effects on the above parameters compared with the standard dose of Xocai beverage. This equivalency will be driven by overall antioxidant content and the extra fat and sugar in the nuggets will not significantly block the beneficial effects. The high dose of Xocai beverage will be only minimally more beneficial than the standard dose.
Who is Eligible to Participate in the Study?
Inclusion Criteria:
1) Age Range : Age 18-79
2) BMI <35, and of good general health.
Exclusion Criteria:
If regularly use lipid-altering medications (including niacin over 100 mg/d and DHA/EPA over one gram/d), alcohol, tobacco or antioxidant supplmenets (other than a standard multiple vitamin) and if they have a history of diabetes mellitus, active liver, renal or thyroid disease, or active cancer.
How long will the Study run?
Scheduled to end June 2007
What is/are the Locations of this Clinical Trial?
Cardiovascular Genetics
420 Chipeta Way, Room 1160
Salt Lake City, UT 84108
Who can I Contact for Additional Information on this Trial?
If you are interested in receiving more information about this Clinical Trial, please contact the Clinical Trial Coordinator listed in the shaded box to the right under "Contact Information". |
| |
More information on this Clinical Trial:
Status:
Open to Enrollment
Contact Information:
Name: Stacey Larrinaga-Shum
Telephone: 801-581-3888x273
Email: s.larrinaga-shum@utah.edu Principal Investigator:
Eliot A. Brinton, M.D.
Please Note:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clincal research trials only. If you have specific questions which require clincal expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.
Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study. | |
|
Physicians
