Effects of Xoçai Antioxidant Supplements on Atherosclerosis Risk Factors - Full Text View

Sponsors and Collaborators:	University of Utah MXI Corporation
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00666250

Purpose

An antioxidant dietary supplement made from cocoa powder, and extracts of acai, grape and blueberry will be tested for effects on blood sugar, blood pressure, cholesterol and related parameters in human subjects.

Condition	Intervention
Hypertension Dyslipidemia Hyperglycemia	Dietary Supplement: Xocai Activ drink

MedlinePlus related topics: Antioxidants Dietary Supplements High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Single Blind (Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	Effects of Xoçai Antioxidant Supplements on Atherosclerosis Risk Factors

Further study details as provided by University of Utah:

Primary Outcome Measures:

Blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma Lipids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Arterial Compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Fasting and post-challenge glucose and insulin [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
urine microalbumin/creatinine ratio [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	January 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Baseline: No Intervention Baseline values off chocolate supplement
Low Dose: Experimental Low dose of dietary supplement 30 ml tid (Activ Xocai Drink)	Dietary Supplement: Xocai Activ drink proprietary blend of cocoa powder and extracts of acai, grape and blueberry
High-dose: Experimental High dose of dietary supplement 90 ml tid (Xocai Activ drink)	Dietary Supplement: Xocai Activ drink proprietary blend of cocoa powder and extracts of acai, grape and blueberry

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Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy adult not taking cocoa supplements

Exclusion Criteria:

diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666250

Locations

United States, Utah
Cardiovascular Genetics, University of Utah
Salt Lake City, Utah, United States, 84108

Sponsors and Collaborators

University of Utah

MXI Corporation

Investigators

Principal Investigator:

Eliot Brinton, MD

University of Utah

More Information

Cardiovascular Genetics, University of Utah This link exits the ClinicalTrials.gov site

Responsible Party:	Cardiovascular Genetics, University of Utah ( Eliot A. Brinton )
Study ID Numbers:	Xocai01
Study First Received:	April 22, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00666250
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

blood pressure
dyslipidemia
hyperglycemia

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Metabolic Diseases
Hyperglycemia
Vascular Diseases
Arteriosclerosis

Metabolic disorder
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009