CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers

This is an open-label proof-of-concept human clinical study on the effects of consumption of
a nutraceutical blend. Data collection will include a core set of data pertaining to chronic
pain and inflammatory markers. Additional data collection will include blood pressure,
weight, and overall wellness.

An open-label study design will be used to evaluate the effects of consumption of the
nutraceutical product CytoQuel. The product is marketed broadly for many types of
inflammation-related health issues. The study is of 8 weeks' duration, with evaluation at
baseline, 2, and 8 weeks of product consumption. Study participants will be randomized to one
of two groups, taking either 3 caps once daily, or two caps twice daily.

At each visit, the following measurements and procedures are performed: Blood pressure and
ankle brachial index, questionnaires pertaining to pain and activities of daily living, and a
blood draw. The blood is used for testing of cytokines and vascular health related
biomarkers.

Inclusion Criteria:

- Adult people of either gender;

- Age 30-75 years (inclusive);

- BMI between 20.0 and 34.9 (inclusive);

- Experiencing chronic pain in at least one specific anatomical area for more than 6
months.

Exclusion Criteria:

- Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus,
inflammatory bowel disease, Celiac disease);

- Known active cardiovascular health issues;

- Cancer during past 12 months;

- Chemotherapy during past 12 months;

- Currently taking blood pressure medication;

- Currently taking blood thinning medication (81mg aspirin allowed);

- Currently taking cholesterol-lowering medication (for example: statins);

- Currently taking Coumadin;

- Currently taking nutritional supplements judged by the study coordinator to negate or
camouflage the effects of the test product;

- Currently taking prescription pain medications;

- Getting regular joint injections (such as cortisone shots);

- Major surgery within the past 3 months;

- Major trauma within the past 3 months;

- Any other condition or observation that the investigator judges may adversely affect
the person's ability to complete the study;

- 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;

- Hypersensitivity or known allergy to green tea or black tea;

- Participation in another research study involving an investigational product in the
past month;

- Planned surgery within 2 weeks of completing the study;

- Previous major surgery to stomach or intestines [(absorption of test product may be
altered) minor surgery is not a problem, including appendix and gallbladder removal];

- Unwilling to maintain a constant intake of supplements over the duration of the study;

- Women who are pregnant, nursing, or trying to become pregnant.