Chronic Musculoskeletal PainPhase 2KOPENCT06580912
Krill Oil for Pain in Elders
A Phase 2 study testing Krill oil and Mixed vegetable oil in people with Chronic Musculoskeletal Pain, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Krill oil and Mixed vegetable oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to 17 Dec 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Claude D. Pepper Older Americans Independence Center
Gainesville, Florida, 32610
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Krill oil, Mixed vegetable oil
- Keywords
- Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oilDrug
4 grams of krill oil per day
Mixed vegetable oilDietary supplement
4 grams of mixed vegetable oil per day
| Study group | Role | What they receive |
|---|---|---|
| Krill oil | Experimental | 4 grams of krill oil per day Receives: Drug: Krill oil |
| Mixed vegetable oil | Placebo comparator | 4 grams of mixed vegetable oil per day Receives: Dietary Supplement: Mixed vegetable oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With 70% or Greater Adherence Based on Self-reported Daily Diary
Adherence defined as taking at least 70% of assigned capsules during the 12-week intervention, based on participant diary records.
Measured: From baseline through final assessment, up to 12 weeks.
Participants With 70% or Greater Adherence Based on Capsule Counts
Adherence defined as taking at least 70% of assigned capsules during the 12-week intervention, based on capsule count records.
Measured: From baseline through final assessment, up to 12 weeks.
Overall Acceptability Score on the Medicine Acceptability Questionnaire
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.
Measured: 6 weeks and 12 weeks
Secondary outcomes (2)
Omega-3 Index
Omega-3 Index was calculated as eicosapentaenoic acid plus docosahexaenoic acid, or EPA+DHA, expressed as a percentage of total fatty acids in erythrocytes.
Measured: Baseline, 6 weeks, and 12 weeks
High-sensitivity C-reactive Protein
High-sensitivity C-reactive protein (hs-CRP) will be measured at every visit as an inflammatory biomarker and for safety monitoring.
Measured: Baseline, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start17 Jan 2025
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Javier A Tamargo, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580912
- Sponsor's protocol ID
- IRB202400581
- Other IDs
- P30AG028740
- Acronym
- KOPE
- Status last verified
- Feb 2025
- First submitted
- 26 Aug 2024
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28542024Stonehouse 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.
PubMed 35880828Suzuki 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.
PubMed 27701428Alkhedhairi 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.
PubMed 35504165Laslett 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.
PubMed 38776073Tamargo JA, Simic K, Capote S, Przkora R, Sibille KT, Cruz-Almeida Y, Anton SD. Krill Oil for Pain in Elders: protocol for a pilot, double-blind, randomised controlled trial to evaluate the efficacy of 4 g/d krill oil supplementation for chronic musculoskeletal pain and mobility limitations in older adults. Br J Nutr. 2026 May 18:1-11. doi: 10.1017/S0007114526107557. Online ahead of print.
PubMed 42144560Tamargo JA, Carvajal E, Simic K, Przkora R, Anton SD, Cruz-Almeida Y. Pilot Randomized Controlled Trial of Krill Oil Supplementation for Chronic Musculoskeletal Pain in Older Adults. J Nutr. 2026 Jun;156(6):101517. doi: 10.1016/j.tjnut.2026.101517. Epub 2026 Apr 1.
PubMed 41933837