Clinical trial NCT03690609: CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
Official title: CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in pain level from baseline
timeFrame: 8 weeks.
Secondary outcomes:
measure: Change in blood pressure from baseline
timeFrame: 8 weeks.
Other outcomes:
measure: Change in Fibrinogen level from baseline
timeFrame: 8 weeks.
measure: Change in von Willebrand Factor from baseline
timeFrame: 8 weeks.
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
affiliation: NIS Labs
name: Gitte Jensen
role: PRINCIPAL_INVESTIGATOR
References: