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

NCT ID: NCT01881178

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation

Keywords

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CRP Nopalea Fruit Juice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Apricot

Supplement: Apricot Juice

Group Type ACTIVE_COMPARATOR

NOPALEA

Intervention Type DIETARY_SUPPLEMENT

Nopalea

Supplement: Nopalea

Group Type EXPERIMENTAL

NOPALEA

Intervention Type DIETARY_SUPPLEMENT

Interventions

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NOPALEA

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mark Mattie

OTHER

Sponsor Role lead

Responsible Party

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Mark Mattie

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mark e Mattie

Role: STUDY_DIRECTOR

UBCNM

Locations

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Trivita Wellness Center

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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Nopalea

Identifier Type: -

Identifier Source: org_study_id