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

40 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Krill Oil for musculoskeletal pain?

Research suggests that krill oil, which contains omega-3 fatty acids, may help reduce inflammation and oxidative damage, which are often linked to pain. Additionally, krill oil has shown benefits in managing conditions like arthritis, which involves joint pain. ^{1 2 3 4 5}

Is krill oil safe for humans?

Krill oil has been studied in humans and is generally considered safe, with research showing it can have health benefits similar to fish oil, such as improving blood lipid levels and reducing inflammation. ^{1 3 6 7 8}

How is krill oil treatment different from other treatments for musculoskeletal pain?

Krill oil is unique because it contains omega-3 fatty acids in a phospholipid form, which may be more easily absorbed by the body compared to other sources like fish oil. Additionally, krill oil has anti-inflammatory properties that could help reduce pain and inflammation, making it a novel option for managing musculoskeletal pain. ^{1 2 3 6 9}

What is the purpose of this trial?

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.

Research Team

Javier A Tamargo, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Krill oil reduces intestinal inflammation by improving epithelial integrity and impairing adherent-invasive Escherichia coli pathogenicity. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Effects of krill oil and lean and fatty fish on cardiovascular risk markers: a randomised controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Supplementation of diet with krill oil protects against experimental rheumatoid arthritis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women. [2016]

6. England pubmed.ncbi.nlm.nih.gov

The effect of krill oil supplementation on skeletal muscle function and size in older adults: A randomised controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the effects of Neptune Krill Oil on the clinical course of hyperlipidemia. [2013]

8. United States 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. [2017]

9. England 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. [2015]