Krill Oil for Musculoskeletal Pain

(KOPE Trial)

Overseen By Javier A Tamargo, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Anticoagulants, Opioids, NSAIDs, SSRIs

Disqualifiers: Diabetes, Cardiovascular, Hypertension, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether krill oil can reduce chronic pain and improve movement in older adults with musculoskeletal pain. Researchers compare krill oil, rich in omega-3s, to a placebo made of vegetable oil. Individuals with chronic pain in areas such as the hips, knees, or lower back for over three months, who experience moderate difficulty moving, may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as anticoagulants, full-dose aspirin, opioids, high-dose NSAIDs, steroids, SSRIs, and omega-3 supplements. If you are on any of these, you may need to stop them to participate.

Is there any evidence suggesting that krill oil is likely to be safe for humans?

Research has shown that krill oil is generally safe for use for up to six months. Some individuals might experience side effects such as an upset stomach, reduced appetite, or heartburn, but most tolerate it well. One study on knee osteoarthritis found that krill oil helped reduce pain and stiffness and improved movement. These studies found krill oil to be a safe option for those with joint pain. However, more research is needed to determine its effectiveness for other types of pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for musculoskeletal pain?

Researchers are excited about krill oil for musculoskeletal pain because it offers a natural alternative to standard treatments like NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) and opioids, which often come with unwanted side effects. Unlike these conventional options, krill oil is rich in omega-3 fatty acids, which have anti-inflammatory properties that can help alleviate pain. Additionally, krill oil might be easier on the stomach and have fewer side effects than typical pain relievers. This makes it a promising option for those looking for a more natural and potentially safer way to manage their pain.

What evidence suggests that krill oil might be an effective treatment for musculoskeletal pain?

Research has shown that krill oil, which participants in this trial may receive, might help reduce joint pain and improve movement, particularly in adults with mild to moderate knee osteoarthritis (OA), a condition where joints become stiff and sore. Some studies suggest krill oil can ease knee pain, reduce stiffness, and improve function. However, other research has produced mixed results, with some studies finding no significant pain relief compared to a placebo. In this trial, the placebo comparator is mixed vegetable oil. Krill oil is rich in omega-3 fatty acids, which might help because it is absorbed better and contains more nutrients than regular fish oil. Overall, there is some promise, but results vary, and more research is needed to confirm its effectiveness for ongoing joint pain in older adults. ^{3 5 6 7 8}

Who Is on the Research Team?

Javier A Tamargo, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older who have chronic pain in their hips, knees, or lower back. Participants must be able to take oral supplements and follow the study's lifestyle guidelines. They should also be willing to stick with the study procedures and be available throughout its duration.

Inclusion Criteria

I have signed and dated the consent form.

I am willing and able to follow all study procedures for its duration.

I agree to follow the study's lifestyle guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 4 grams of krill oil or placebo daily to assess the impact on pain and physical function

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Krill Oil

Trial Overview The trial is testing whether krill oil can help manage chronic musculoskeletal pain and improve physical function in older adults compared to a mixed vegetable oil supplement. It's a pilot study designed to see if it's feasible to conduct larger research on this topic.

How Is the Trial Designed?

Group I: Krill oil Experimental Treatment 1 Intervention

4 grams of krill oil per day

Group II: Mixed vegetable oil Placebo Group 1 Intervention

4 grams of mixed vegetable oil per day

Krill Oil is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Krill Oil for:

• Dietary supplement for heart health and joint pain

Approved in European Union as Krill Oil for:

• Dietary supplement for heart health and joint pain

Approved in Japan as Krill Oil for:

• Dietary supplement for heart health and joint pain

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving mice on a high-fat diet for 10 weeks, krill oil supplementation led to approximately 15% less body weight gain and significantly reduced liver fat accumulation.

The beneficial effects of krill oil were linked to the activation of AMP-activated protein kinase, which plays a crucial role in regulating glucose and lipid metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Krill Oil Supplementation Improves Dyslipidemia and Lowers Body Weight in Mice Fed a High-Fat Diet Through Activation of AMP-Activated Protein Kinase. Yang, G., Lee, J., Lee, S., et al.[2017]

In a study of 102 healthy older adults aged 65 and above, 6 months of krill oil supplementation (4g/day) led to significant improvements in muscle function, including a 9.3% increase in knee extensor maximal torque and a 10.9% increase in grip strength compared to a control group.

Krill oil supplementation also resulted in a notable increase in muscle size, with a 3.5% increase in vastus lateralis muscle thickness, alongside significant enhancements in the erythrocyte fatty acid profile, indicating improved omega-3 levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of krill oil supplementation on skeletal muscle function and size in older adults: A randomised controlled trial. Alkhedhairi, SA., Aba Alkhayl, FF., Ismail, AD., et al.[2022]

Krill oil has been shown to improve intestinal barrier integrity and promote healing in inflamed epithelial cells, as demonstrated by its ability to restore levels of E-cadherin and ZO-1, which are crucial for cell adhesion.

Additionally, krill oil effectively reduces the adhesion and invasion of pathogenic Escherichia coli in epithelial cells and decreases the expression of pro-inflammatory cytokines, suggesting its potential as a treatment for intestinal inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Krill oil reduces intestinal inflammation by improving epithelial integrity and impairing adherent-invasive Escherichia coli pathogenicity. Costanzo, M., Cesi, V., Prete, E., et al.[2016]

In a three-month study involving 120 patients with hyperlipidemia, krill oil (1-3 g daily) significantly reduced total cholesterol, LDL, triglycerides, and increased HDL levels compared to both fish oil and placebo.

Krill oil was found to be more effective than fish oil at lower doses for managing blood lipids and glucose levels, indicating its potential as a superior option for treating hyperlipidemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effects of Neptune Krill Oil on the clinical course of hyperlipidemia. Bunea, R., El Farrah, K., Deutsch, L.[2013]

Recent research has highlighted krill oil as a potential alternative to fish oil for managing health conditions like hyperlipidemia, inflammation, and arthritis due to its high content of omega-3 fatty acids (EPA and DHA).

A review of 10 peer-reviewed clinical studies indicates that krill oil is generally safe for human consumption, supporting its growing popularity in the health supplement market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief review of krill oil history, research, and the commercial market. Kwantes, JM., Grundmann, O.[2015]

In a study involving 42 DBA/1 mice with collagen-induced arthritis, krill oil significantly reduced arthritis severity and hind paw swelling compared to a control diet, especially in the later phases of the study.

Unlike fish oil, which increased certain inflammatory cytokines, krill oil did not affect serum cytokine levels, suggesting it may provide anti-inflammatory benefits without exacerbating inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation of diet with krill oil protects against experimental rheumatoid arthritis. Ierna, M., Kerr, A., Scales, H., et al.[2021]

In a study involving 76 overweight and obese participants, 4 weeks of krill oil supplementation significantly increased plasma levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) without causing adverse effects.

The krill oil was well tolerated, showing no significant safety concerns, and it also led to a decrease in blood urea nitrogen compared to menhaden oil, indicating potential metabolic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women. Maki, KC., Reeves, MS., Farmer, M., et al.[2016]

In an 8-week study with 36 healthy participants, krill oil supplementation led to significant increases in total lipids, phospholipids, and cholesterol levels, while also reducing fasting blood glucose levels, indicating potential cardiovascular benefits.

Both krill oil and fish consumption increased plasma levels of marine n-3 fatty acids, but only fish intake significantly raised vitamin D levels, highlighting the unique health benefits of each source.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of krill oil and lean and fatty fish on cardiovascular risk markers: a randomised controlled trial. Rundblad, A., Holven, KB., Bruheim, I., et al.[2022]

In a study involving 72 Sprague-Dawley rats over 6 weeks, krill oil led to significantly greater deposition of DHA and DPA in tissues compared to fish oil, indicating a more favorable metabolic fate for these fatty acids.

The absorption of fatty acids was generally higher in female rats, but the type of oil (krill vs. fish) had minimal impact on absorption; instead, the differences in how the body processed these oils (anabolism vs. catabolism) were key to the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic fate (absorption, β-oxidation and deposition) of long-chain n-3 fatty acids is affected by sex and by the oil source (krill oil or fish oil) in the rat. Ghasemifard, S., Hermon, K., Turchini, GM., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11112499/

Krill Oil for Knee Osteoarthritis: A Randomized Clinical Trial In this randomized clinical trial that included 262 adults, compared with placebo, 2 g/d of krill oil supplementation did not improve knee pain as measured on a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06580912

Study Details | NCT06580912 | Krill Oil for Pain in Elders 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.

3. journals.lww.com journals.lww.com/md-journal/fulltext/2025/02140/krill_oil_for_knee_osteoarthritis__a_meta_analysis.18.aspx

Krill oil for knee osteoarthritis: A meta-analysis of randomized The pooled data from the included studies indicate potential modest improvements in knee pain and functionality associated with krill oil ...

4. link.springer.com link.springer.com/article/10.1007/s10787-024-01543-7

Krill oil supplementation for knee pain: a systematic review ... This study found that krill oil supplementation did not significantly improve knee pain, stiffness, or lipid profile, although it may help knee physical ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522000843

Krill oil improved osteoarthritic knee pain in adults with mild ... Krill oil was safe to consume and resulted in modest improvements in knee pain, stiffness, and physical function in adults with mild to moderate knee OA.

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1172/krill-oil

Krill Oil - Uses, Side Effects, and More When taken by mouth: Krill oil is possibly safe when used for up to 6 months. Side effects might include stomach upset, decreased appetite, heartburn, fishy ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9437987/

Krill oil improved osteoarthritic knee pain in adults with mild to ... Krill oil was safe to consume and resulted in modest improvements in knee pain, stiffness, and physical function in adults with mild to moderate knee OA.

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2819125

Krill Oil for Knee Osteoarthritis: A Randomized Clinical Trial In 3 randomized clinical trials (RCTs), daily krill oil reduced some aspects of knee pain, functional impairment, and stiffness among people ...