Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness. (114-012)

Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness. A Randomized, Double-blind, Placebo-controlled Clinical Study

The purpose for this protocol is to perform a double-blind, randomized, placebo-controlled, parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical product on physical and mental energy levels and overall wellness.

Study Overview

• Status: Completed
• Conditions: Range of Motion
• Intervention / Treatment: Dietary supplement: Prickly pear juice; Dietary supplement: Pear-flavored juice

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • NIS Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults of either gender;
• 35-75 years old;
• Chronic joint/muscle related pain for at least past 6 months;
• Body mass index (BMI) at or below 34.9 kg/m2.

Exclusion Criteria:

• Bariatric surgery;
• Diagnosed with diabetes Type I;
• Taking medication for diabetes Type II;
• Known serious chronic health condition;
• Serious active illness within past 12 months;
• Major surgery within the past 3 months;
• Major trauma within the past 3 months;
• Alcohol consumption of more than four standard units/day (for example more than four regular 12 oz beers (5% alcohol), four small 5-oz glasses of wine (12% alcohol), or four 1.5 oz shots of 80-proof spirits), or more than 28 units per week;
• Daily consumption of Nopalea or similar juice products during the past month;
• Currently taking anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
• Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable);
• Use of oral, inhaled or injected steroid medication within the last 6 months (for example: prednisone, dexamethasone). Nasal sprays for allergies are allowed;
• Any other significant disease or disorder that the investigator judges may put the subject at risk because of participation in the study, or may influence the result of the study;
• Any other condition or observation that the investigator judges may adversely affect the person's ability to complete the study;
• Women of child-bearing potential: Pregnant, breast-feeding, or trying to become pregnant;
• Known allergies to ingredients in the test and placebo products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prickly pear juice; Prickly pear juice, 3 oz daily for 8 weeks.	Dietary supplement: Prickly pear juice; 3 ounces daily for 8 weeks.
Placebo Comparator: Pear-flavored juice; Pear-flavored juice, 3 oz daily for 8 weeks.	Dietary supplement: Pear-flavored juice; 3 ounces daily for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.	Baseline, 2 weeks, and 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Digital inclinometry for measuring mobility of neck, back, hips, knees, and shoulders.	Baseline and 8 weeks.

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc
• Investigators: Principal Investigator: Gitte Jensen, NIS Labs

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): June 25, 2019
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NIS114012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No