Nutramax Joint Health Formulation Biochemical Response Study

NCT02614274 | Completed Results

• 1 other identifier: 1213242
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The Nutramax test article is a nutritional supplement that contains several ingredients shown to potentially provide benefit to patients suffering from a painful and sometimes debilitating condition of the knee called "osteoarthritis." This is a pilot study that is intended to determine whether results from a proprietary testing panel conducted on blood and urine samples will correlate with data from physical examination and validated surveys that measure participants' quality of life and physical capabilities.

Conditions

Osteoarthritis, Knee

Keywords

knee; pain; osteoarthritis; nutraceutical; nutrition; supplement; non-surgical; biomarker; joint health

Outcome Measures

Primary Outcomes (2)

• Serum Biomarkers

  Blood will be assessed using a proprietary panel of biomarkers of inflammation. Blood and urine were collected, processed, and analyzed using a proprietary panel of biomarkers using the Luminex system as previously described (Garner, et al; Roller, et al). In addition, serum hsCRP was analyzed.

  42 days

• Urine Biomarkers

  Urine will be assessed using a proprietary panel of biomarkers of inflammation.

  42 days

Secondary Outcomes (4)

• Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement

  42 days

• Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score)

  42 days

• Patient Reported Survey to Assess: Pain, Stiffness, and Physical Function in Patients With Hip and/or Knee Osteoarthritis (OA) Via WOMAC (Western Ontario and McMaster Universities Arthritis Index)

  42 days

• Patient Reported Survey to Assess Symptoms and Function in Daily Living Via IKDC (International Knee Documentation Committee) Subject Exam

  42 days

Study Arms (1)

Nutraceutical joint health formulation

EXPERIMENTAL

A Proprietary Blend

Dietary Supplement: Nutraceutical joint health formulation

Interventions

Nutraceutical joint health formulation DIETARY_SUPPLEMENT

A Proprietary Blend

Nutraceutical joint health formulation

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is able to understand and sign the informed consent.
• Subject is willing and able to comply with the protocol.
• Male or female subjects of any race, aged 40 to 64 years
• Subject has a BMI of 24 to 40 kg/m2
• Subject has had pain in one or both knees for a minimum of 15 days within the 30 days prior to the start of the study.
• Subject has had symptoms of knee pain for at least 6 months.
• Subject has been diagnosed within the previous 30 days with moderate to severe knee osteoarthritis - based on attending physician's diagnosis from physical exam in conjunction with Kellgren-Lawrence X-ray grade of ≥ 2 (radiographs taken within previous 30 days must be available to the investigator, or be obtained at the screening visit).
• Subject can walk.
• Before study enrollment, subject routinely uses acetaminophen (at any dose) with a history of therapeutic benefit.
• Subject has a visual analogue scale (VAS) score of ≥ 4 at the initial visit. Subject may continue taking acetaminophen at the screening but will not have taken additional analgesics for at least 48 hours prior to the initial visit.
• Female subject abstains from sexual intercourse, is surgically sterile, post-menopausal, or agrees to use a FDA-approved method of birth control.

You may not qualify if:

• Subject has any of the following medical conditions:
• active heart disease - defined as currently under the care of a cardiologist
• high blood pressure (≥ 140/90 mmHg)
• renal or hepatic impairment/disease
• Type I or II diabetes
• Bipolar or major depressive disorder or a history of other psychiatric illness requiring hospitalization in the past 6 months.
• Parkinson's disease
• unstable thyroid disease
• immune disorder (such as HIV/AIDS)
• multiple sclerosis or any other autoimmune disorder
• any arthritic condition, other than OA, affecting a joint other than the knee
• acute septic arthritis
• fibromyalgia or other chronic pain syndromes (OA in locations other than knee allowed)
• gout and hyperuricemia
• peptic ulcer disease and/or history of upper gastrointestinal bleeding

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Nutramax Laboratories, Inc.: collaborator

Study Sites (1)

University of Missouri, Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: James L. Cook, Director of Research
• Organization: University of Missouri

cookjl@health.missouri.edu

573-884-4689

Study Officials

• James L Cook, DVM PhD OTC

  University of Missouri, Missouri Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DVM, PhD, OTC, Director, Comparative Orthopaedic Laboratory, Orthopaedic Research Division & Mizzou BioJoint Center

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 25, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)