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

Study Overview
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Brief Summary
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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.

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

Conditions
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Range of Motion

Intervention / Treatment
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* Dietary Supplement: Prickly pear juice
* Dietary Supplement: Pear-flavored juice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blinded, randomized, placebo-controlled, parallel-arm clinical study design will be used.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prickly pear juice<br>Prickly pear juice, 3 oz daily for 8 weeks. | Dietary Supplement: Prickly pear juice<br>* 3 ounces daily for 8 weeks.<br>|
| Placebo Comparator: Pear-flavored juice<br>Pear-flavored juice, 3 oz daily for 8 weeks. | Dietary Supplement: Pear-flavored juice<br>* 3 ounces daily for 8 weeks.<br>|

What is the study measuring?
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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. |