CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Dietary supplement: CytoQuel; Dietary supplement: CytoQuel

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • NIS Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.; Dietary supplement: CytoQuel; 2 capsules twice 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; 3 capsules daily.; Dietary supplement: CytoQuel; 2 capsules twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure from baseline	Systolic and diastolic blood pressure.	8 weeks.

Other Outcome Measures

Outcome Measure	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	8 weeks.

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc
• Investigators: Principal Investigator: Gitte Jensen, NIS Labs

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): January 19, 2018

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: NIS143002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data will be published. At this time it is not determined whether individual data will be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No