CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Nutraceutical intervention, 3 capsules daily. Participants will consume the nutraceutical blend CytoQuel at a dose of 1850 mg, by consuming 3 capsules daily in the morning. |
Dietary Supplement: CytoQuel
3 capsules daily.
|
| Active Comparator: Nutraceutical intervention, 2 capsules twice daily. 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
2 capsules twice daily.
|
Outcome Measures
Primary Outcome Measures
- Change in pain level from baseline [8 weeks.]
Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
Secondary Outcome Measures
- Change in blood pressure from baseline [8 weeks.]
Systolic and diastolic blood pressure.
Other Outcome Measures
- Change in Fibrinogen level from baseline [8 weeks.]
Plasma fibrinogen level pg/mL
- Change in von Willebrand Factor from baseline [8 weeks.]
von Willebrand Factor level pg/mL
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult people of either gender;
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Age 30-75 years (inclusive);
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BMI between 20.0 and 34.9 (inclusive);
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Experiencing chronic pain in at least one specific anatomical area for more than 6 months.
Exclusion Criteria:
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Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus, inflammatory bowel disease, Celiac disease);
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Known active cardiovascular health issues;
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Cancer during past 12 months;
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Chemotherapy during past 12 months;
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Currently taking blood pressure medication;
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Currently taking blood thinning medication (81mg aspirin allowed);
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Currently taking cholesterol-lowering medication (for example: statins);
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Currently taking Coumadin;
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Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
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Currently taking prescription pain medications;
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Getting regular joint injections (such as cortisone shots);
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Major surgery within the past 3 months;
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Major trauma within the past 3 months;
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Any other condition or observation that the investigator judges may adversely affect the person's ability to complete the study;
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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;
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Hypersensitivity or known allergy to green tea or black tea;
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Participation in another research study involving an investigational product in the past month;
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Planned surgery within 2 weeks of completing the study;
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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];
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Unwilling to maintain a constant intake of supplements over the duration of the study;
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Women who are pregnant, nursing, or trying to become pregnant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NIS Labs | Klamath Falls | Oregon | United States | 97601 |
Sponsors and Collaborators
- Natural Immune Systems Inc
Investigators
- Principal Investigator: Gitte Jensen, NIS Labs
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIS143002