The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein (NOPALEA)
December 29, 2014 updated by: Mark Mattie
The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein (NOPALEA)
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
287
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 06473
- Trivita Wellness Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Apricot
Supplement: Apricot Juice
|
|
|
Experimental: Nopalea
Supplement: Nopalea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HS-CRP
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mark e Mattie, UBCNM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
June 17, 2013
First Submitted That Met QC Criteria
June 18, 2013
First Posted (Estimate)
June 19, 2013
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 29, 2014
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nopalea
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.