NCT02614274

Nutramax Joint Health Formulation Biochemical Response Study

Pilot Assessment of the Biochemical Response of a Novel Nutraceutical Joint Health Formulation Using a Multiplexed Biomarker Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 40 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

Osteoarthritis (OA) of the knee is a significant source of morbidity, especially in patients over the age of 40 and is associated with more than $90 billion in US health care costs annually. While a myriad of clinical interventions are available, the mainstays of OA therapy are the NSAIDs, a class of compounds with well documented side effects including death; the risks of which increase with patient age and chronic use. Assessing the effectiveness of OA treatment modalities is often complicated by a high placebo effect, making purely clinical assessment of outcomes difficult. It is therefore desirable to develop an objective assessment tool for both the diagnosis/staging of knee OA and patient response to interventional therapies. Participants in this study will receive a formulation of the nutraceutical (test article). They will be asked to take 3 pills at once per day for 40-44 days. There will be either 4 or 5 study visits. If participants have been using certain medications or dietary supplements, they will be asked to return one week from the initial screening, making a total of 5 visits in the study. If they have not been using key medications or dietary supplements, then study activities will begin on the day of the initial screening and they will only have 4 study visits. Participants will be asked to complete a series of questionnaires about their health, and have their blood drawn (15 mls or about 3 teaspoons), and provide a urine sample at 4 visits. In addition, at the first visit, we will collect information from participants' medical record and they will have a physical exam.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutraceutical joint health formulation	A Proprietary Blend

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2015-11-25
• Last updated: 2018-11-05
• Results posted: 2018-11-05

Locations

1 site across 1 country: United States