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Effects of Xoçai Antioxidant Supplements on Atherosclerosis Risk Factors

This study has been completed.
Sponsor:
Collaborator:
MXI Corporation
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00666250
First received: April 22, 2008
Last updated: April 23, 2008
Last verified: April 2008
History of Changes
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Effects of Xoçai Antioxidant Supplements on Atherosclerosis Risk Factors

Resource links provided by NLM:

U.S. FDA Resources

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
No Intervention: Baseline
Baseline values off chocolate supplement
Experimental: Low Dose
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
Other Names:
  • Xocai Activ drink;
  • cocoa powder,
  • acai extract,
  • grape extract,
  • blueberry extract
Experimental: High-dose
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
Other Names:
  • Xocai Activ drink;
  • cocoa powder,
  • acai extract,
  • grape extract,
  • blueberry extract

  Show Detailed Description

  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

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

No publications provided

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

Keywords provided by University of Utah:
blood pressure
dyslipidemia
hyperglycemia

Additional relevant MeSH terms:
Atherosclerosis
Hyperglycemia
Hypertension
Dyslipidemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
 Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013