Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

Study Overview
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Brief Summary
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This study is intended to assess the effects of astaxanthin use on pain, physical function, and inflammation as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS) scores and levels of inflammatory biomarkers in subjects taking astaxanthin. If improvements in pain, function, and/or markers of inflammation could be demonstrated with the use of astaxanthin, this may suggest the potential for astaxanthin to be used in management of knee osteoarthritis (and possibly other forms of osteoarthritis) with less evident toxicity than seen with the presently available standard therapies (e.g. NSAIDS, opioids).

Official Title
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Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Dietary Supplement: astaxanthin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Symptoms of knee pain Radiographic evidence of mild to moderate arthritis Able to provide written consent on their own behalf Exclusion Criteria: Pregnancy Current tobacco use Current substance abuse (alcohol or drug) Presence of significant cardiovascular, pulmonary, hepatic, or renal disease Prior history of knee trauma or surgery Gout or pseudogout Significant depression or anxiety scores on PHQ-9 and GAD-7, or pre-existing diagnosis of a significant mental health disorder Presence of other chronic pain syndromes such as chronic low back or neck pain, fibromyalgia, or complex regional pain syndrome Presence of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease Symptomatic involvement of multiple other joints with osteoarthritis Known allergy to fish or astaxanthin BMI greater than 35 Participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Astaxanthin<br>Astaxanthin 12mg twice daily by mouth | Dietary Supplement: astaxanthin<br>* astaxanthin capsules 12 mg twice daily<br>|
| Placebo Comparator: Placebo<br>Placebo twice daily by mouth | Other: Placebo<br>* placebo capsules twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS Numeric Rating Pain Scale | Pain improvement in subjects is the primary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity Scale 1a tool will be used. This scale ranges from 0-10, with 0 representing no pain and 10 representing the worst pain imaginable. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS Pain interference score | Reduction in pain interference is a secondary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Interference Short Form 6b will be used as the survey tool for pain interference. This is a set of 6 questions to assess the degree to which pain has interfered with daily activities. There are 5 levels of pain interference from 0 (none at all) to 5 (very much or always). The higher the score, the greater the pain interference. | 20 weeks | 
| Change in PROMIS Physical function score | Improvement in physical function is a secondary outcome measure. The PROMIS Physical Function Short Form 6b will be used as the survey tool for physical limitation. There are 5 levels of limitation to physical function from 0 (without any difficulty) to 5 (unable to do). The higher the score, the greater the limitation | 20 weeks | 
| Change in Erythrocyte Sedimentation Rate | Change in ESR (mm/hr) | 20 weeks | 
| Change in C-reactive protein levels | Change in CRP levels (mg/L) | 20 weeks | 
| Change in Interleukin-6 levels | Change in IL-6 levels (pg/mL) | 20 weeks | 
| Change in Cartilage Oligomeric Matrix Protein levels | Change in COMP levels (ng/mL) | 20 weeks |