Osteoarthritis, KneeNCT02614274
Nutramax Joint Health Formulation Biochemical Response Study
A study testing Nutraceutical joint health formulation in people with Osteoarthritis, Knee, run by University of Missouri-Columbia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Nutraceutical joint health formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- any medical condition deemed exclusionary by the Principal Investigator (PI)
- Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
- Subject has had a significant injury to the target joint within the past 12 months.
- Subject plans to have knee surgery in the next 2 months.
- Subject has had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medication.
- Subject has an allergy to avocados, soybeans, shellfish or any other ingredient in the test product.
- Subject requires additional analgesic or a change from acetaminophen. (Subjects requiring acetaminophen dose adjustments may remain in the study and all such dose and/or schedule changes shall be recorded in the raw data and daily patient diary).
- Subject is currently taking any medication or suffers from a medical condition, deemed to potentially interfere with the objectives of the study as determined by the PI.
- Subject has a history of drug or alcohol abuse in the past 12 months.
- Subject is currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
- Subject does not agree to use a FDA-approved method of birth control or is pregnant, lactating, or planning to become pregnant during the study period.
- Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- Subject is participating or has participated in another research study within 30 days prior to screening.
- Subject has used, or intends to use, any oral or injectable NSAID (e.g., ketorolac, aspirin, ibuprofen, naproxen, diclofenac, etc.) within 7 days prior to screening through study completion.
- Subject has been treated with oral corticosteroids within 4 weeks prior to screening.
- Subject had intra-articular corticosteroids in the target joint within 3 months prior to screening.
- Subjects may not take any dietary, vitamin, mineral, or herbal supplements within 7 days prior to Day 0 through study completion. For subjects taking such products at time of the initial visit, a seven-day washout period prior to study Day 1 is allowed EXCEPT for joint health/anti-inflammatory products (see # 18).
- Subjects who are currently taking or have taken for ≥ 30 consecutive days OR ≥ 60 days total, within the 180 days prior to screening, dietary products intended to decrease inflammation, body pain and/or improve joint health; including, but not necessarily limited to, glucosamine, chondroitin, avocado-soybean unsaponifiable (ASU), and methylsulfonylmethane (MSM) shall be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri, Missouri Orthopaedic Institute
Columbia, Missouri, 65212
About this study
Official title: Pilot Assessment of the Biochemical Response of a Novel Nutraceutical Joint Health Formulation Using a Multiplexed Biomarker Approach
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.
Read the 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
- Being tested
- Nutraceutical joint health formulation
- Keywords
- knee, pain, osteoarthritis, nutraceutical, nutrition, supplement, non-surgical, biomarker, joint health
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutraceutical joint health formulationDietary supplement
A Proprietary Blend
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical joint health formulation | Experimental | A Proprietary Blend Receives: Dietary Supplement: Nutraceutical joint health formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 days
Urine Biomarkers
Urine will be assessed using a proprietary panel of biomarkers of inflammation.
Measured: 42 days
Secondary outcomes (4)
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software.
Mean+-SD among of improvement is reported.
Measured: 42 days
Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score)
Knee injury and Osteoarthritis Outcome Score (KOOS). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 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)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC). A lower score indicates less severe symptoms, a higher score indicates more severe symptoms. The range of scores as is follows: 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Function.
Measured: 42 days
Patient Reported Survey to Assess Symptoms and Function in Daily Living Via IKDC (International Knee Documentation Committee) Subject Exam
International Knee Documentation Committee (IKDC). Each subscale is scored from 0-100, with 100 being no limitation with activities of daily living or sports activities and the absence of symptoms.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Nutramax Laboratories, Inc.
- Responsible party
- Principal investigator, James Cook, University of Missouri-Columbia
- Investigators
- James L Cook, DVM PhD OTC, Principal investigator, University of Missouri, Missouri Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614274
- Sponsor's protocol ID
- 1213242
- Status last verified
- Apr 2018
- First submitted
- 24 Nov 2015
- Last updated
- 5 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Assessment of the Biochemical Response of a Novel Nutraceutical Joint Health Formulation Using a Multiplexed Biomarker Approach
- ClinicalTrials.gov ID
- NCT02614274
- Acronym / sponsor ID
- 1213242
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee, pain, osteoarthritis, nutraceutical, nutrition, supplement, non-surgical, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Nutramax Laboratories, Inc.
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical joint health formulation | Experimental | Dietary Supplement: Nutraceutical joint health formulationA Proprietary Blend |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (33 listed)
- Subject has any of the following medical conditions:
- Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
- Subject has had a significant injury to the target joint within the past 12 months.
- Subject plans to have knee surgery in the next 2 months.
- Subject has had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutraceutical joint health formulationA Proprietary Blend | Dietary supplement | Nutraceutical joint health formulation |
Primary outcome
Serum Biomarkers
Time frame: 42 days
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.
Urine Biomarkers
Time frame: 42 days
Urine will be assessed using a proprietary panel of biomarkers of inflammation.
4 secondary outcomes
Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement
Time frame: 42 days
Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: 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)
Time frame: 42 days
Patient Reported Survey to Assess Symptoms and Function in Daily Living Via IKDC (International Knee Documentation Committee) Subject Exam
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James L Cook, DVM PhD OTC principal investigator
University of Missouri, Missouri Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutraceutical joint health formulation in people with Osteoarthritis, Knee, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Biomarkers (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.