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



Status:Recruiting
Healthy:No
Age Range:35 - 75
Updated:3/15/2019
Start Date:July 17, 2018
End Date:December 31, 2019
Contact:Gitte Jensen
Email:gitte@nislabs.com
Phone:5418840112

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

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.


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.
We found this trial at
1
site
Klamath Falls, Oregon 97601
Phone: 541-884-0112
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Klamath Falls, OR
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