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OpenTrials
Completed

NCT Number: NCT03619265

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

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.

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Key information

Conditions

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIS Labs

Klamath Falls, Oregon, 97601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prickly pear juice

Dietary Supplement

3 ounces daily for 8 weeks.

Pear-flavored juice

Dietary Supplement

3 ounces daily for 8 weeks.

Primary outcomes

  1. Pain level

    Time frame: 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 outcomes

  1. Range of motion

    Time frame: Baseline and 8 weeks.

    Digital inclinometry for measuring mobility of neck, back, hips, knees, and shoulders.

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Registry information

Official study title

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

Acronym: 114-012

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 7, 2018
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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