Pain
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTCytoQuel
3 capsules daily.
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure from baseline | 8 weeks. | Systolic and diastolic blood pressure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed