Clinical trial NCT06580912: Krill Oil for Pain in Elders
Official title: Krill Oil for Pain and Physical Function in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Musculoskeletal Pain
Keywords: Chronic Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic musculoskeletal pain contributes to mobility disability among older adults. Nutritional interventions, like omega-3 fatty acids, may help manage pain and improve physical function. Supplementation with krill oil may offer advantages to fish oil due to better absorption and additional nutrients. This pilot study aims to assess the feasibility of a clinical trial to determine the impact of krill oil supplementation on pain and function in older adults, informing future research.

Detailed description: Mobility is a critical factor in the maintenance of independence and quality of life of older adults. Chronic musculoskeletal pain contributes to mobility disability disproportionately among older adults. Current treatments for pain and functional decline are often ineffective and add to heightened risks of polypharmacy in older adults. As such, nutritional interventions can play a significant role in promoting health and longevity, managing pain, and enhancing physical function in older adults. Omega (ω)-3 polyunsaturated fatty acids (PUFAs) are essential nutrients that are well recognized for their anti-inflammatory and cardioprotective benefits, as well as their analgesic and anti-nociceptive properties. Most American adults do not meet the recommendations for ω-3 intakes, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), found primarily in seafood. Due to competing pathways, an elevated ω-6 to ω-3 ratio contributes to an overproduction of pro-inflammatory eicosanoids and the development of chronic diseases. A high ω-6:ω-3 ratio is associated with higher chronic pain prevalence and increased pain severity. Additionally, ω-3 PUFAs may play a role in the preservation of muscle and physical function in older adults. Low levels of ω-3s in blood are associated with reduced muscle strength, slower gait speed, and mobility disability among older adults. Considered largely safe and cost-effective, ω-3 supplementation may be crucial to increasing the intake of these essential nutrients and achieving optimal levels among older adults. Although the use of EPA and DHA has been incorporated into several guidelines, a scarcity of data has prevented the development of strong recommendations on the use of ω-3 supplementation for the maintenance of physical function in older adults, particularly those with chronic musculoskeletal pain. Krill oil has been recently proposed as an advantageous alternative to traditional fish oil supplements, due to a greater bioavailability of EPA and DHA and additional bioactive compounds. The goal of the proposed pilot study is to assess the feasibility of a 3-month randomized controlled trial to determine the effectiveness of krill oil supplementation on pain and physical function in older adults with chronic musculoskeletal pain. The investigators will enroll 40 older adults (≥60 years) who will be randomly assigned to 4 g krill oil (1,288 mg/d EPA+DHA, 0.45 mg astaxanthin, 320 mg choline) daily or matched placebo (mixed lipids without EPA and DHA). The investigators will determine the impact of krill oil supplementation on the omega-3 index (%EPA+DHA in erythrocytes), the ω-6/ω-3 ratio, and inflammatory biomarkers in blood, and obtain preliminary evidence of its impact on pain and physical function in older adults. The findings of this pilot will inform a future fully-powered randomized controlled trial by assessing the feasibility and acceptability of krill oil supplementation among older U.S. adults with chronic musculoskeletal pain.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥60 years
* Exhibiting chronic musculoskeletal pain of the hip, knees, or lower back (\>3 months)
* Average pain ≥4 on a 0-10 numeric rating scale
* Exhibiting moderate mobility limitations (Short Physical Performance Battery score 4-10)
* Ability to take oral supplements and be willing to adhere to the supplementation regimen
* Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

* Any known coagulation or bleeding disorders
* Standing regimen of anticoagulants or full-dose aspirin
* Regular use of opioids or high-dose NSAIDs
* Taking medication known to affect muscle (e.g. steroids)
* Taking selective serotonin reuptake inhibitors (SSRIs)
* Omega-3 supplementation within the past 3 months
* High consumption of fatty fish (\>2 servings/week)
* Habitual supplementation with other complementary medicines/supplements that may affect the study results, including St. John's Wort
* Known allergy to seafood
* Clinically significant conditions: diabetes, severe cardiovascular disease, seizure disorders, uncontrolled hypertension (\>150/90mmhg at baseline), cancer or cancer that has been in remission \>5 years
* History of atrial fibrillation or atrial flutter
* Dementia
* History of smoking, alcohol abuse, or illicit drug use
* Ambulatory impairments which would limit the ability to perform physical function tests
* Treatment with another investigational drug or other intervention within 3 months
* Planning a surgical procedure during the study period
* Planning to permanently leave the area during the study period

Primary outcomes:
measure: Omega-3 Index
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Graded Chronic Pain Scale-Revised (GCPS-R)
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline and 12 weeks
measure: 6-Minute Walk Test (6MWT)
timeFrame: Baseline and 12 weeks
measure: Handgrip Strength Test (HGST)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Inflammatory Biomarkers
timeFrame: Baseline and 12 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: 6 weeks and 12 weeks
measure: Medicine Acceptability Questionnaire (MAQ)
timeFrame: 6 weeks and 12 weeks
measure: Pepper Assessment Tool for Disability (PAT-D)
timeFrame: Baseline and 12 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Screening, 6 weeks, and 12 weeks
measure: NIH Toolbox Cognition Battery
timeFrame: Baseline and 12 weeks
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Baseline and 12 weeks
measure: EuroQol 5 Dimension 5 Level (EQ-5D-5L)
timeFrame: Baseline and 12 weeks
measure: Brief Pittsburgh Sleep Quality Index (B-PSQI)
timeFrame: Baseline and 12 weeks
measure: Pain Self-Efficacy Questionnaire
timeFrame: Baseline and 12 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline and 12 weeks
measure: Geriatric Depression Scale-Short Form
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Claude D. Pepper Older Americans Independence Center
state: Florida
Study officials:
affiliation: University of Florida
name: Javier A Tamargo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sibille KT, King C, Garrett TJ, Glover TL, Zhang H, Chen H, Reddy D, Goodin BR, Sotolongo A, Petrov ME, Cruz-Almeida Y, Herbert M, Bartley EJ, Edberg JC, Staud R, Redden DT, Bradley LA, Fillingim RB. Omega-6: Omega-3 PUFA Ratio, Pain, Functioning, and Distress in Adults With Knee Pain. Clin J Pain. 2018 Feb;34(2):182-189. doi: 10.1097/AJP.0000000000000517.
citation: Stonehouse W, Benassi-Evans B, Bednarz J, Vincent AD, Hall S, Hill CL. Krill oil improved osteoarthritic knee pain in adults with mild to moderate knee osteoarthritis: a 6-month multicenter, randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2022 Sep 2;116(3):672-685. doi: 10.1093/ajcn/nqac125.
citation: Suzuki Y, Fukushima M, Sakuraba K, Sawaki K, Sekigawa K. Krill Oil Improves Mild Knee Joint Pain: A Randomized Control Trial. PLoS One. 2016 Oct 4;11(10):e0162769. doi: 10.1371/journal.pone.0162769. eCollection 2016.
citation: Alkhedhairi SA, Aba Alkhayl FF, Ismail AD, Rozendaal A, German M, MacLean B, Johnston L, Miller AA, Hunter AM, Macgregor LJ, Combet E, Quinn TJ, Gray SR. The effect of krill oil supplementation on skeletal muscle function and size in older adults: A randomised controlled trial. Clin Nutr. 2022 Jun;41(6):1228-1235. doi: 10.1016/j.clnu.2022.04.007. Epub 2022 Apr 20.
citation: Laslett LL, Scheepers LEJM, Antony B, Wluka AE, Cai G, Hill CL, March L, Keen HI, Otahal P, Cicuttini FM, Jones G. Krill Oil for Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2024 Jun 18;331(23):1997-2006. doi: 10.1001/jama.2024.6063.