Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness.

Not Applicable

Completed

• Conditions: Range of Motion
• Interventions: Dietary Supplement: Pear-flavored juice; Dietary Supplement: Prickly pear juice

• Registration Number: NCT03619265
• Lead Sponsor: Natural Immune Systems Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-10
• Study Start: 2018-07-17
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-07
• Primary Completion: 2019-06-25
• Study Completion: 2020-02-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pear-flavored juice	Pear-flavored juice	Pear-flavored juice, 3 oz daily for 8 weeks.
Prickly pear juice	Prickly pear juice	Prickly pear juice, 3 oz daily for 8 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Range of motion	Baseline and 8 weeks.	Digital inclinometry for measuring mobility of neck, back, hips, knees, and shoulders.

Trial Locations

Locations (1)

NIS Labs; 🇺🇸 Klamath Falls, Oregon, United States