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The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein (NOPALEA)

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ClinicalTrials.gov Identifier: NCT01881178
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Mark Mattie, University of Bridgeport

Brief Summary:
This study has been developed to investigate the anti-inflammatory effects of a commercial product (Nopalea) containing Prickly Pear Cactus Fruit Juice in healthy adults. The research method employs a double blind, placebo controlled, and time-series (repeat measures) design with high-sensitivity C-Reactive Protein (HS-CRP) serving as a marker for inflammation - testing for levels of CRP at time points: baseline (pre-test), 8 weeks (60 days) and 12 weeks (90 days). The final time point (i.e., 12 weeks) will serve as the post-test. It is expected that baseline CRP levels in healthy participants will decline.

Condition or disease Intervention/treatment Phase
Inflammation Dietary Supplement: NOPALEA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein (NOPALEA)
Study Start Date : May 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Apricot
Supplement: Apricot Juice
Dietary Supplement: NOPALEA
Experimental: Nopalea
Supplement: Nopalea
Dietary Supplement: NOPALEA



Primary Outcome Measures :
  1. HS-CRP [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Live within traveling distance of the research center. Access to a telephone in their residence. Between 35 and 75 years of age Not currently ingesting Nopalea Not pregnant, planning to become pregnant, or nursing a child Not currently taking anti-inflammatory medications Medically stable - i.e. no recent major change in the last 3 weeks of prescription or non- prescription medication Not diagnosed with Type 1 Diabetes Not diagnosed with depression Not diagnosed with an acquired or congenital immune system deficiency

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): NCT01881178


Locations
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United States, Arizona
Trivita Wellness Center
Scottsdale, Arizona, United States, 06473
Sponsors and Collaborators
Mark Mattie
Investigators
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Study Director: Mark e Mattie UBCNM

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Responsible Party: Mark Mattie, Associate Professor, University of Bridgeport
ClinicalTrials.gov Identifier: NCT01881178     History of Changes
Other Study ID Numbers: Nopalea
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: June 2013
Keywords provided by Mark Mattie, University of Bridgeport:
CRP
Nopalea
Fruit
Juice
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes