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

M

Mark Mattie

Status

Completed

Conditions

Inflammation

Treatments

Dietary Supplement: NOPALEA

Study type

Interventional

Funder types

Other

Identifiers

NCT01881178
Nopalea

Details and patient eligibility

About

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.

Enrollment

287 patients

Sex

All

Ages

35 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

287 participants in 2 patient groups

Apricot
Active Comparator group
Description:
Supplement: Apricot Juice
Treatment:
Dietary Supplement: NOPALEA
Nopalea
Experimental group
Description:
Supplement: Nopalea
Treatment:
Dietary Supplement: NOPALEA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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