Back to resultsThe Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein (NOPALEA)
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOPALEA
Sponsored by
About this trial
This is an interventional prevention trial for Inflammation focused on measuring CRP, Nopalea, Fruit, Juice
Eligibility 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
Sites / Locations
- Trivita Wellness Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Apricot
Nopalea
Arm Description
Supplement: Apricot Juice
Supplement: Nopalea
Outcomes
Primary Outcome Measures
HS-CRP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01881178
Brief Title
The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein
Acronym
NOPALEA
Official Title
The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein (NOPALEA)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Mattie
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
CRP, Nopalea, Fruit, Juice
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apricot
Arm Type
Active Comparator
Arm Description
Supplement: Apricot Juice
Arm Title
Nopalea
Arm Type
Experimental
Arm Description
Supplement: Nopalea
Intervention Type
Dietary Supplement
Intervention Name(s)
NOPALEA
Primary Outcome Measure Information:
Title
HS-CRP
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark e Mattie
Organizational Affiliation
UBCNM
Official's Role
Study Director
Facility Information:
Facility Name
Trivita Wellness Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
06473
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein
We'll reach out to this number within 24 hrs