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Effects of Xoçai Antioxidant Supplements on Atherosclerosis Risk Factors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666250
First Posted: April 24, 2008
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
  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: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effects of Xoçai Antioxidant Supplements on Atherosclerosis Risk Factors

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Plasma Lipids [ Time Frame: 4 weeks ]
  • Arterial Compliance [ Time Frame: 4 weeks ]
  • Fasting and post-challenge glucose and insulin [ Time Frame: 4 weeks ]
  • urine microalbumin/creatinine ratio [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adult not taking cocoa supplements

Exclusion Criteria:

  • diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666250


Locations
United States, Utah
Cardiovascular Genetics, University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Eliot Brinton, MD University of Utah
  More Information

Additional Information:
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00666250     History of Changes
Other Study ID Numbers: Xocai01
First Submitted: April 22, 2008
First Posted: April 24, 2008
Last Update Posted: February 8, 2016
Last Verified: April 2008

Keywords provided by University of Utah:
blood pressure
dyslipidemia
hyperglycemia

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