Krill Oil for Pain in Elders

NCT06580912 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: IRB202400581P30AG028740
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Musculoskeletal Pain

Keywords

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Feasibility Metrics: Recruitment, Attrition, and Intervention Adherence

  Feasibility will be assessed using prespecified benchmarks for recruitment, attrition, and intervention adherence. Feasibility criteria were defined as achieving at least 80% of the recruitment target within 12 months, less than 20% attrition, and greater than 70% adherence to the intervention.

  Through study completion, up to 15 months

• Medicine Acceptability Questionnaire (MAQ)

  Tool designed to assess patients' perceptions and experiences of taking medications. It evaluates factors such as ease of use, taste, and overall satisfaction, providing insights into patient adherence and preferences.

  6 weeks and 12 weeks

Secondary Outcomes (2)

• Omega-3 Index

  Baseline, 6 weeks, and 12 weeks

• High-sensitivity C-reactive protein

  Baseline, 6 weeks, and 12 weeks

Other Outcomes (15)

• Pain, Enjoyment of Life, and General Activities (PEG) Scale

  Baseline, 6 weeks, and 12 weeks

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Baseline, 6 weeks, and 12 weeks

• Patient Global Impression of Change (PGIC)

  6 weeks and 12 weeks

Study Arms (2)

Krill oil

EXPERIMENTAL

4 grams of krill oil per day

Drug: Krill oil

Mixed vegetable oil

PLACEBO COMPARATOR

4 grams of mixed vegetable oil per day

Dietary Supplement: Mixed vegetable oil

Interventions

Krill oil DRUG

4 grams of krill oil per day

Krill oil

Mixed vegetable oil DIETARY_SUPPLEMENT

4 grams of mixed vegetable oil per day

Mixed vegetable oil

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UF Claude D. Pepper Older Americans Independence Center

Gainesville, Florida, 32610, United States

Location

Related Publications (6)

• 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.

  PMID: 28542024 BACKGROUND

• 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.

  PMID: 35880828 BACKGROUND

• 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.

  PMID: 27701428 BACKGROUND

• 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.

  PMID: 35504165 BACKGROUND

• 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. Erratum In: JAMA. 2024 Sep 26. doi: 10.1001/jama.2024.20532.

  PMID: 38776073 BACKGROUND

• 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 Mar 31:101517. doi: 10.1016/j.tjnut.2026.101517. Online ahead of print.

  PMID: 41933837 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier A Tamargo, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: January 17, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: April 17, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)