Nutramax Joint Health Formulation Biochemical Response Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02614274
• Date of registration: 24/11/2015
• Prospective Registration: No
• Primary sponsor: University of Missouri-Columbia
• Public title: Nutramax Joint Health Formulation Biochemical Response Study
• Scientific title: Pilot Assessment of the Biochemical Response of a Novel Nutraceutical Joint Health Formulation Using a Multiplexed Biomarker Approach
• Date of first enrolment: November 2014
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02614274
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: James L Cook, DVM PhD OTC
• Affiliation: University of Missouri, Missouri Orthopaedic Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject is able to understand and sign the informed consent.

2. Subject is willing and able to comply with the protocol.

3. Male or female subjects of any race, aged 40 to 64 years

4. Subject has a BMI of 24 to 40 kg/m2

5. 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.

6. Subject has had symptoms of knee pain for at least 6 months.

7. 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).

8. Subject can walk.

9. Before study enrollment, subject routinely uses acetaminophen (at any dose) with a
history of therapeutic benefit.

10. 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.

11. Female subject abstains from sexual intercourse, is surgically sterile,
post-menopausal, or agrees to use a FDA-approved method of birth control.

Exclusion Criteria:

1. Subject has any of the following medical conditions:

1. active heart disease - defined as currently under the care of a cardiologist

2. high blood pressure (= 140/90 mmHg)

3. renal or hepatic impairment/disease

4. Type I or II diabetes

5. Bipolar or major depressive disorder or a history of other psychiatric illness
requiring hospitalization in the past 6 months.

6. Parkinson's disease

7. unstable thyroid disease

8. immune disorder (such as HIV/AIDS)

9. multiple sclerosis or any other autoimmune disorder

10. any arthritic condition, other than OA, affecting a joint other than the knee

11. acute septic arthritis

12. fibromyalgia or other chronic pain syndromes (OA in locations other than knee
allowed)

13. gout and hyperuricemia

14. peptic ulcer disease and/or history of upper gastrointestinal bleeding

15. any medical condition deemed exclusionary by the Principal Investigator (PI)

2. Subject has a history of cancer (except localized skin cancer without metastases or in
situ cervical cancer) within five years prior to screening.

3. Subject has had a significant injury to the target joint within the past 12 months.

4. Subject plans to have knee surgery in the next 2 months.

5. Subject has had an asthma attack, hives, or other allergic reaction with aspirin or
any other NSAID medication.

6. Subject has an allergy to avocados, soybeans, shellfish or any other ingredient in the
test product.

7. 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).

8. 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.

9. Subject has a history of drug or alcohol abuse in the past 12 months.

10. 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.

11. 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.

12. 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.

13. Subject is participating or has participated in another research study within 30 days
prior to screening.

14. 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.

15. Subject has been treated with oral corticosteroids within 4 weeks prior to screening.

16. Subject had intra-articular corticosteroids in the target joint within 3 months prior
to screening.

17. 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).

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.



Age minimum: 40 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis, Knee

Intervention(s)

Dietary Supplement: Nutraceutical joint health formulation

Primary Outcome(s)

Urine Biomarkers [Time Frame: 42 days]

Serum Biomarkers [Time Frame: 42 days]

Secondary Outcome(s)

Patient Reported Survey to Assess Symptoms and Function in Daily Living Via IKDC (International Knee Documentation Committee) Subject Exam [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 Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score) [Time Frame: 42 days]

Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement [Time Frame: 42 days]

Secondary ID(s)

1213242

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nutramax Laboratories, Inc.

Results

• Results available: Yes
• Date Posted: 05/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02614274