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

Range of Motion Clinical Trial

— 114-012  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619265
• Other study ID #: NIS114012
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: February 10, 2020

Study information

• Verified date: March 2020
• Source: Natural Immune Systems Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 10, 2020
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Range of Motion

Intervention

Dietary Supplement:
• Prickly pear juice
3 ounces daily for 8 weeks.
• Pear-flavored juice
3 ounces daily for 8 weeks.

Locations

Country	Name	City	State
United States	NIS Labs	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Range of motion	Digital inclinometry for measuring mobility of neck, back, hips, knees, and shoulders.	Baseline and 8 weeks.