Evaluation of Activity Levels, Inflammatory Markers, and Overall Wellness.
Completed · Not applicable · Has a placebo group
Conditions studied: Range of Motion
In brief
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.
Key facts
- Study ID
- NCT03619265
- Run by
- Natural Immune Systems Inc
- People needed
- 40
- Starts
- 2018-07-17
- Expected to finish
- 2020-02-10
- Last updated by the study team
- 2020-03-12
Who can join
Age: 35 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- NIS Labs — Klamath Falls, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.