Phase 2
N=40
Krill Oil for Pain in Elders
Chronic Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT06580912 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Participants With 70% or Greater Adherence Based on Self-reported Daily Diary — 18; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Krill oil (Drug); Mixed vegetable oil (Dietary_supplement)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With 70% or Greater Adherence Based on Self-reported Daily Diary |
18; 17 | — |
| PRIMARY Participants With 70% or Greater Adherence Based on Capsule Counts |
15; 15 | — |
| PRIMARY Overall Acceptability Score on the Medicine Acceptability Questionnaire |
7.4; 7.7; 8.1; 7.4 | — |
| SECONDARY Omega-3 Index |
4.3; 4.5; 7.4; 4.5; 7.5; 4.6 | <0.0001 sig |
| SECONDARY High-sensitivity C-reactive Protein |
3.2; 3.6; 3.2; 4.8; 2.9; 5.4 | 0.578 |
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. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06580912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.