CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
NCT ID: NCT03690609
Last Updated: 2020-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2017-09-21
2018-01-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
CytoQuel
3 capsules daily.
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.
CytoQuel
2 capsules twice daily.
Interventions
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CytoQuel
3 capsules daily.
CytoQuel
2 capsules twice daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
75 Years
ALL
Yes
Sponsors
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Natural Immune Systems Inc
OTHER
Responsible Party
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Gitte Jensen, Ph.D.
Research director
Principal Investigators
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Gitte Jensen
Role: PRINCIPAL_INVESTIGATOR
NIS Labs
Locations
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NIS Labs
Klamath Falls, Oregon, United States
Countries
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Other Identifiers
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NIS143002
Identifier Type: -
Identifier Source: org_study_id
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