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 |
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.
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
Click here to add this to my saved trials