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Completed

NCT Number: NCT06580912

Krill Oil for Pain in Elders

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UF Claude D. Pepper Older Americans Independence Center

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Krill oil

Drug

4 grams of krill oil per day

Mixed vegetable oil

Dietary Supplement

4 grams of mixed vegetable oil per day

Primary outcomes

  1. Participants With 70% or Greater Adherence Based on Self-reported Daily Diary

    Time frame: From baseline through final assessment, up to 12 weeks.

    Adherence defined as taking at least 70% of assigned capsules during the 12-week intervention, based on participant diary records.

  2. Participants With 70% or Greater Adherence Based on Capsule Counts

    Time frame: From baseline through final assessment, up to 12 weeks.

    Adherence defined as taking at least 70% of assigned capsules during the 12-week intervention, based on capsule count records.

  3. Overall Acceptability Score on the Medicine Acceptability Questionnaire

    Time frame: 6 weeks and 12 weeks

    The Medicine Acceptability Questionnaire (MAQ) overall acceptability item was rated on a 0 to 10 scale. Scores range from 0 to 10, with higher scores indicating greater acceptability.

Secondary outcomes

  1. Omega-3 Index

    Time frame: Baseline, 6 weeks, and 12 weeks

    Omega-3 Index was calculated as eicosapentaenoic acid plus docosahexaenoic acid, or EPA+DHA, expressed as a percentage of total fatty acids in erythrocytes.

  2. High-sensitivity C-reactive Protein

    Time frame: Baseline, 6 weeks, and 12 weeks

    High-sensitivity C-reactive protein (hs-CRP) will be measured at every visit as an inflammatory biomarker and for safety monitoring.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Krill Oil for Pain and Physical Function in Older Adults

Acronym: KOPE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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