Range of Motion
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPrickly pear juice
3 ounces daily for 8 weeks.
DIETARY_SUPPLEMENTPear-flavored juice
3 ounces daily for 8 weeks.
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
A double-blinded, randomized, placebo-controlled, parallel-arm clinical study design will be used.
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Range of motion | Baseline and 8 weeks. | Digital inclinometry for measuring mobility of neck, back, hips, knees, and shoulders. |
Countries
United States
Outcome results
None listed