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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Show all 17Show fewer

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

Other trials in United States

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 groups in NCT06580912
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.

17 Jan 202517 Dec 2025

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)

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 28542024
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.
PubMed 35880828
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.
PubMed 27701428
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.
PubMed 35504165
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.
PubMed 38776073
Tamargo 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 42144560
Tamargo 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Krill Oil for Pain and Physical Function in Older Adults
ClinicalTrials.gov ID: NCT06580912
Acronym / sponsor ID: KOPE / IRB202400581
Conditions: Chronic Musculoskeletal Pain
Keywords: Chronic Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 17 Jan 2025 (actual)
Primary completion: 17 Dec 2025 (actual)
Study completion: 17 Dec 2025 (actual)
First posted: 30 Aug 2024 (actual)
Results: Posted 13 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Krill oil	Experimental	Drug: Krill oil4 grams of krill oil per day
Mixed vegetable oil	Placebo comparator	Dietary Supplement: Mixed vegetable oil4 grams of mixed vegetable oil per day

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (17 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Krill oil4 grams of krill oil per day	Drug	Krill oil
Mixed vegetable oil4 grams of mixed vegetable oil per day	Dietary supplement	Mixed vegetable oil

Primary outcome

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.
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.
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.

2 secondary outcomes

Omega-3 Index
Time frame: Baseline, 6 weeks, and 12 weeks
High-sensitivity C-reactive Protein
Time frame: Baseline, 6 weeks, and 12 weeks

Results and safety

Results posted to the registry on 13 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Krill Oil	20	18
Mixed Vegetable Oil	20	20

Primary outcome: Participants With 70% or Greater Adherence Based on Self-reported Daily Diary

Time frame: From baseline through final assessment, up to 12 weeks.. Count of participants. Unit: Participants

Measure	Krill Oil n = 18	Mixed Vegetable Oil n = 19
Value	18	17

Population analysed: Analysis includes participants with evaluable self-reported diary adherence data during the 12-week intervention. Of 38 completers, 1 participant had missing diary records.

Primary outcome: Participants With 70% or Greater Adherence Based on Capsule Counts

Time frame: From baseline through final assessment, up to 12 weeks.. Count of participants. Unit: Participants

Measure	Krill Oil n = 18	Mixed Vegetable Oil n = 18
Value	15	15

Population analysed: Analysis includes participants with evaluable capsule count adherence data during the 12-week intervention. Participants were classified as adherent if capsule-count adherence was ≥70%.

Primary outcome: Overall Acceptability Score on the Medicine Acceptability Questionnaire

Time frame: 6 weeks and 12 weeks. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Krill Oil n = 18	Mixed Vegetable Oil n = 20
Week 6	7.4 (2.8)	7.7 (2.4)
Week 12	8.1 (2.0)	7.4 (2.5)

Population analysed: Analysis includes participants with available MAQ overall acceptability data at each time point.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline through study completion, up to 12 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Krill Oil	0 of 20 (0%)	14 of 20 (70%)	0 of 20
Mixed Vegetable Oil	0 of 20 (0%)	16 of 20 (80%)	0 of 20

Limitations and caveats (from the sponsor): This was a pilot feasibility study with a small sample size and was not powered to detect definitive treatment effects on clinical or biomarker outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28542024Sibille 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.
Background: PubMed 35880828Stonehouse 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.
Background: PubMed 27701428Suzuki 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.
Background: PubMed 35504165Alkhedhairi 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.
Background: PubMed 38776073Laslett 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.
Results publication: PubMed 42144560Tamargo 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.
Results publication: PubMed 41933837Tamargo 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javier A Tamargo, PhD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With 70% or Greater Adherence Based on Self-reported Daily Diary (time frame: From baseline through final assessment, up to 12 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06580912, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.