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

Inflammation Clinical Trial

— NOPALEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881178
• Other study ID #: Nopalea
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: December 29, 2014
• Start date: May 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2013
• Source: University of Bridgeport
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• NOPALEA

Locations

Country	Name	City	State
United States	Trivita Wellness Center	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mark Mattie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HS-CRP		12 weeks	No