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

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

The purpose for this protocol is to perform an open-label parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical product on chronic pain, vascular health, inflammation, and overall wellness.

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.