Krill Oil for Pain in Elders (KOPE)

May 11, 2026 updated by: University of Florida

Krill Oil for Pain and Physical Function in Older Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Claude D. Pepper Older Americans Independence Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Krill oil
4 grams of krill oil per day
Drug: Krill oil
4 grams of krill oil per day
Placebo Comparator: Mixed vegetable oil
4 grams of mixed vegetable oil per day
Dietary supplement: Mixed vegetable oil
4 grams of mixed vegetable oil per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline through final assessment, up to 12 weeks.
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.
From baseline through final assessment, up to 12 weeks.
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.
6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, and 12 weeks
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.
Baseline, 6 weeks, and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Baseline, 6 weeks, and 12 weeks
Well-validated and widely utilized measure of pain symptoms and physical disability. It is comprised of 24 items to evaluate three domains: pain, stiffness, and physical function. Responses can be summated for domain-specific scores, as well as a global score.
Baseline, 6 weeks, and 12 weeks
Short Physical Performance Battery (SPPB)
Time Frame: Baseline and 12 weeks
Widely used geriatric assessment designed to evaluate the physical performance and mobility of older adults. It consists of a series of simple tests that assess three major components: balance, gait speed, and lower extremity strength (chair stand test). Each component is scored on a scale from 0 to 4, with higher scores indicating better performance. An SPPB of ≤10 is predictive of mobility disability and all-cause mortality.
Baseline and 12 weeks
6-Minute Walk Test (6MWT)
Time Frame: Baseline and 12 weeks
Simple, inexpensive, sub-maximal exercise test commonly used to assess functional capacity and endurance in older adults. Participants are instructed to cover as much distance as possible in 6 minutes along a rectangular pathway. Normative data for 6MWT performance by age in older adults is available for comparison.
Baseline and 12 weeks
Handgrip Strength Test (HGST)
Time Frame: Baseline and 12 weeks
Handgrip strength is a measure of physical function and is suggested as a biomarker of aging. Maximal grip strength for each hand will be measured using a handheld dynamometer.
Baseline and 12 weeks
Patient Global Impression of Change (PGIC)
Time Frame: 6 weeks and 12 weeks
Self-reported measure that assesses a patient's overall perception of improvement or decline in their condition following treatment. It is typically used in clinical trials to gauge the efficacy of an intervention from the patient's perspective, with responses ranging from "very much improved" to "very much worse."
6 weeks and 12 weeks
Pepper Assessment Tool for Disability (PAT-D)
Time Frame: Baseline and 12 weeks
23-item instrument measuring 5 domains of function in older adults: mobility, transferring, upper extremity, activities of daily living (ADL), and instrumental activities of daily living (IADL).
Baseline and 12 weeks
NIH Toolbox Cognition Battery
Time Frame: Baseline and 12 weeks
The NIH Toolbox Cognition Battery is comprised of 7 tests that measure 8 abilities within 6 major cognitive domains: executive function, episodic memory, language, processing speed, working memory, and attention. Composite scores will be calculated for (1) fluid, (2) crystallized, and (3) global cognitive function.
Baseline and 12 weeks
Fear Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Baseline and 12 weeks
Self-report tool used to assess the extent to which individuals with musculoskeletal pain, particularly lower back pain, avoid physical activity and work due to fear that it will exacerbate their pain. It helps identify patients who may be at risk of developing chronic pain due to fear-avoidance behaviors.
Baseline and 12 weeks
EuroQol 5 Dimension 5 Level (EQ-5D-5L)
Time Frame: Baseline and 12 weeks
The EQ-5D-5L is a standardized instrument used to measure health-related quality of life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity, allowing for a detailed assessment of an individual's overall health status.
Baseline and 12 weeks
Brief Pittsburgh Sleep Quality Index (B-PSQI)
Time Frame: Baseline and 12 weeks
A shortened version of the original Pittsburgh Sleep Quality Index, designed to quickly assess sleep quality over a one-month period. It measures aspects like sleep duration, sleep disturbances, and daytime dysfunction.
Baseline and 12 weeks
Pain Self-Efficacy Questionnaire
Time Frame: Baseline and 12 weeks
10-item tool used to assess the confidence of individuals with chronic pain in performing daily activities despite their pain. It evaluates how much they believe they can manage or cope with their pain in various situations, providing insights into their psychological resilience and ability to function.
Baseline and 12 weeks
Perceived Stress Scale (PSS)
Time Frame: Baseline and 12 weeks
Psychological tool used to measure the degree to which individuals perceive situations in their lives as stressful. It assesses feelings of stress over the past month, focusing on how unpredictable, uncontrollable, and overloaded respondents find their lives.
Baseline and 12 weeks
Geriatric Depression Scale-Short Form
Time Frame: Baseline and 12 weeks
15-item screening tool designed to assess depression in older adults. It is a simplified version of the original Geriatric Depression Scale and is commonly used due to its brevity and effectiveness in identifying depressive symptoms in elderly populations.
Baseline and 12 weeks
Montreal Cognitive Assessment (MoCA)
Time Frame: Screening, 6 weeks, and 12 weeks
Brief, 10-minute measure of global cognitive function and a screening tool for mild-to-severe cognitive impairment. The test assesses cognitive domains, such as attention, memory, orientation, language, conceptual thinking, and planning. Different versions of the MoCA will be used at each visit to minimize retest effects.
Screening, 6 weeks, and 12 weeks
Pain, Enjoyment of Life, and General Activities (PEG) Scale
Time Frame: Baseline, 6 weeks, and 12 weeks
The PEG scale is a brief, 3-item patient-reported measure of pain derived from the Brief Pain Inventory. It assesses average pain intensity, interference with enjoyment of life, and interference with general activity over the past week, with each item rated from 0 to 10. The overall PEG score is typically calculated as the mean of the three items, with higher scores indicating greater pain severity and interference.
Baseline, 6 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Javier A Tamargo, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Actual)

December 17, 2025

Study Completion (Actual)

December 17, 2025

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202400581
  • P30AG028740 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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