Krill Oil for Pain in Elders (KOPE)
NCT Number: NCT06580912
Acronym: KOPE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Musculoskeletal Pain
Interventions: DRUG: Krill oil|DIETARY_SUPPLEMENT: Mixed vegetable oil
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-14
Completion Date: 2026-03-31

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.

Primary Outcome Measures: Graded Chronic Pain Scale-Revised (GCPS-R), An updated version of the original Graded Chronic Pain Scale (GCPS), a widely used tool in pain research and clinical settings. The GCPS-R assesses the severity and impact of chronic pain by measuring pain intensity and pain-related disability. The scale provides a disability score, which classifies individuals into different levels of pain-related disability. The GCPS-R is useful for both screening and monitoring chronic pain., Baseline, 6 weeks, and 12 weeks|Western Ontario and McMaster Universities Arthritis Index (WOMAC), Well-validated and widely utilized measure of pain symptoms and physical disability. It is comprised of 24 items to evaluate three domains: pain, stiffness, and physical function. Responses can be summated for domain-specific scores, as well as a global score., Baseline, 6 weeks, and 12 weeks|Short Physical Performance Battery (SPPB), Widely used geriatric assessment designed to evaluate the physical performance and mobility of older adults. It consists of a series of simple tests that assess three major components: balance, gait speed, and lower extremity strength (chair stand test). Each component is scored on a scale from 0 to 4, with higher scores indicating better performance. An SPPB of ≤10 is predictive of mobility disability and all-cause mortality., Baseline and 12 weeks|6-Minute Walk Test (6MWT), Simple, inexpensive, sub-maximal exercise test commonly used to assess functional capacity and endurance in older adults. Participants are instructed to cover as much distance as possible in 6 minutes along a rectangular pathway. Normative data for 6MWT performance by age in older adults is available for comparison., Baseline and 12 weeks|Handgrip Strength Test (HGST), Handgrip strength is a measure of physical function and is suggested as a biomarker of aging. Maximal grip strength for each hand will be measured using a handheld dynamometer., Baseline and 12 weeks
Secondary Outcome Measures: Omega-3 Index, Percent EPA+DHA in erythrocytes, Baseline, 6 weeks, and 12 weeks|Inflammatory Biomarkers, We will evaluate concentrations of inflammatory biomarkers, including but not limited to high-sensitivity C-reactive protein, interleukin-6, and tumor necrosis factors-alpha from blood samples., Baseline and 12 weeks|Patient Global Impression of Change (PGIC), Self-reported measure that assesses a patient's overall perception of improvement or decline in their condition following treatment. It is typically used in clinical trials to gauge the efficacy of an intervention from the patient's perspective, with responses ranging from "very much improved" to "very much worse.", 6 weeks and 12 weeks|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|Pepper Assessment Tool for Disability (PAT-D), 23-item instrument measuring 5 domains of function in older adults: mobility, transferring, upper extremity, activities of daily living (ADL), and instrumental activities of daily living (IADL)., Baseline and 12 weeks|Montreal Cognitive Assessment (MoCA), brief, 10-minute measure of global cognitive function and a screening tool for mild-to-severe cognitive impairment. The test assesses cognitive domains, such as attention, memory, orientation, language, conceptual thinking, and planning. Different versions of the MoCA will be used at each visit to minimize retest effects., Baseline and 12 weeks|NIH Toolbox Cognition Battery, The NIH Toolbox Cognition Battery is comprised of 7 tests that measure 8 abilities within 6 major cognitive domains: executive function, episodic memory, language, processing speed, working memory, and attention. Composite scores will be calculated for (1) fluid, (2) crystallized, and (3) global cognitive function., Baseline and 12 weeks|Fear Avoidance Beliefs Questionnaire (FABQ), Self-report tool used to assess the extent to which individuals with musculoskeletal pain, particularly lower back pain, avoid physical activity and work due to fear that it will exacerbate their pain. It helps identify patients who may be at risk of developing chronic pain due to fear-avoidance behaviors., Baseline and 12 weeks|EuroQol 5 Dimension 5 Level (EQ-5D-5L), The EQ-5D-5L is a standardized instrument used to measure health-related quality of life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity, allowing for a detailed assessment of an individual's overall health status., Baseline and 12 weeks|Brief Pittsburgh Sleep Quality Index (B-PSQI), A shortened version of the original Pittsburgh Sleep Quality Index, designed to quickly assess sleep quality over a one-month period. It measures aspects like sleep duration, sleep disturbances, and daytime dysfunction., Baseline and 12 weeks|Pain Self-Efficacy Questionnaire, 10-item tool used to assess the confidence of individuals with chronic pain in performing daily activities despite their pain. It evaluates how much they believe they can manage or cope with their pain in various situations, providing insights into their psychological resilience and ability to function., Baseline and 12 weeks|Perceived Stress Scale (PSS), Psychological tool used to measure the degree to which individuals perceive situations in their lives as stressful. It assesses feelings of stress over the past month, focusing on how unpredictable, uncontrollable, and overloaded respondents find their lives., Baseline and 12 weeks|Geriatric Depression Scale-Short Form, 15-item screening tool designed to assess depression in older adults. It is a simplified version of the original Geriatric Depression Scale and is commonly used due to its brevity and effectiveness in identifying depressive symptoms in elderly populations., Baseline and 12 weeks