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

Natural Immune Systems

Status

Completed

Conditions

Range of Motion

Treatments

Dietary Supplement: Prickly pear juice

Dietary Supplement: Pear-flavored juice

Study type

Interventional

Funder types

Other

Identifiers

NCT03619265

NIS114012

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

35 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.