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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Dietary Supplement: CytoQuel
* Dietary Supplement: CytoQuel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutraceutical intervention, 3 capsules daily.<br>Participants will consume the nutraceutical blend CytoQuel at a dose of 1850 mg, by consuming 3 capsules daily in the morning. | Dietary Supplement: CytoQuel<br>* 3 capsules daily.<br>|
| Active Comparator: Nutraceutical intervention, 2 capsules twice daily.<br>Participants will consume the nutraceutical blend CytoQuel at a dose of 1850 mg, by consuming 4 capsules daily: Two in the morning and two later in the day. | Dietary Supplement: CytoQuel<br>* 2 capsules twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level from baseline | Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated. | 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure from baseline | Systolic and diastolic blood pressure. | 8 weeks. |