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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutraceutical intervention, 3 capsules daily. | Active Comparator | Participants will consume the nutraceutical blend CytoQuel at a dose of 1850 mg, by consuming 3 capsules daily in the morning. |
|
| Nutraceutical intervention, 2 capsules twice daily. | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoQuel | Dietary Supplement | 3 capsules daily. |
| |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure from baseline | Systolic and diastolic blood pressure. | 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fibrinogen level from baseline | Plasma fibrinogen level pg/mL | 8 weeks. |
| Change in von Willebrand Factor from baseline | von Willebrand Factor level pg/mL |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gitte Jensen | NIS Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601 | United States |
Data will be published. At this time it is not determined whether individual data will be made available to other researchers.
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| CytoQuel |
| Dietary Supplement |
2 capsules twice daily. |
|
| 8 weeks. |