cytoquel: clinical documentation on effects on chronic pain, wellness, and reduction of inflammatory markers

Conditions: Pain

Summary: 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.

Eligibility criteria:
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.