Krill Oil for Pain and Physical Function in Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Omega-3 Index
研究概览
简要总结
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.
详细描述
Mobility is a critical factor in the maintenance of independence and quality of life of older adults. Chronic musculoskeletal pain contributes to mobility disability disproportionately among older adults. Current treatments for pain and functional decline are often ineffective and add to heightened risks of polypharmacy in older adults. As such, nutritional interventions can play a significant role in promoting health and longevity, managing pain, and enhancing physical function in older adults. Omega (ω)-3 polyunsaturated fatty acids (PUFAs) are essential nutrients that are well recognized for their anti-inflammatory and cardioprotective benefits, as well as their analgesic and anti-nociceptive properties. Most American adults do not meet the recommendations for ω-3 intakes, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), found primarily in seafood. Due to competing pathways, an elevated ω-6 to ω-3 ratio contributes to an overproduction of pro-inflammatory eicosanoids and the development of chronic diseases. A high ω-6:ω-3 ratio is associated with higher chronic pain prevalence and increased pain severity. Additionally, ω-3 PUFAs may play a role in the preservation of muscle and physical function in older adults. Low levels of ω-3s in blood are associated with reduced muscle strength, slower gait speed, and mobility disability among older adults. Considered largely safe and cost-effective, ω-3 supplementation may be crucial to increasing the intake of these essential nutrients and achieving optimal levels among older adults. Although the use of EPA and DHA has been incorporated into several guidelines, a scarcity of data has prevented the development of strong recommendations on the use of ω-3 supplementation for the maintenance of physical function in older adults, particularly those with chronic musculoskeletal pain. Krill oil has been recently proposed as an advantageous alternative to traditional fish oil supplements, due to a greater bioavailability of EPA and DHA and additional bioactive compounds. The goal of the proposed pilot study is to assess the feasibility of a 3-month randomized controlled trial to determine the effectiveness of krill oil supplementation on pain and physical function in older adults with chronic musculoskeletal pain. The investigators will enroll 40 older adults (≥60 years) who will be randomly assigned to 4 g krill oil (1,288 mg/d EPA+DHA, 0.45 mg astaxanthin, 320 mg choline) daily or matched placebo (mixed lipids without EPA and DHA). The investigators will determine the impact of krill oil supplementation on the omega-3 index (%EPA+DHA in erythrocytes), the ω-6/ω-3 ratio, and inflammatory biomarkers in blood, and obtain preliminary evidence of its impact on pain and physical function in older adults. The findings of this pilot will inform a future fully-powered randomized controlled trial by assessing the feasibility and acceptability of krill oil supplementation among older U.S. adults with chronic musculoskeletal pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Mixed vegetable oil
4 grams of mixed vegetable oil per day
干预措施: Mixed vegetable oil (Dietary Supplement)
Krill oil
4 grams of krill oil per day
干预措施: Krill oil (Drug)
结局指标
主要结局
Omega-3 Index
时间窗: Baseline, 6 weeks, and 12 weeks
Percent EPA+DHA in erythrocytes
Graded Chronic Pain Scale-Revised (GCPS-R)
时间窗: Baseline, 6 weeks, and 12 weeks
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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: Baseline, 6 weeks, and 12 weeks
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.
Short Physical Performance Battery (SPPB)
时间窗: Baseline and 12 weeks
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.
6-Minute Walk Test (6MWT)
时间窗: Baseline and 12 weeks
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.
Handgrip Strength Test (HGST)
时间窗: Baseline and 12 weeks
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.
Feasibility Metrics: Recruitment, Attrition, and Intervention Adherence
时间窗: Through study completion, up to 15 months
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.
Medicine Acceptability Questionnaire (MAQ)
时间窗: 6 weeks and 12 weeks
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.
次要结局
- Inflammatory Biomarkers(Baseline and 12 weeks)
- Patient Global Impression of Change (PGIC)(6 weeks and 12 weeks)
- Medicine Acceptability Questionnaire (MAQ)(6 weeks and 12 weeks)
- Pepper Assessment Tool for Disability (PAT-D)(Baseline and 12 weeks)
- Montreal Cognitive Assessment (MoCA)(Screening, 6 weeks, and 12 weeks)
- NIH Toolbox Cognition Battery(Baseline and 12 weeks)
- Fear Avoidance Beliefs Questionnaire (FABQ)(Baseline and 12 weeks)
- EuroQol 5 Dimension 5 Level (EQ-5D-5L)(Baseline and 12 weeks)
- Brief Pittsburgh Sleep Quality Index (B-PSQI)(Baseline and 12 weeks)
- Pain Self-Efficacy Questionnaire(Baseline and 12 weeks)
- Perceived Stress Scale (PSS)(Baseline and 12 weeks)
- Geriatric Depression Scale-Short Form(Baseline and 12 weeks)
- High-sensitivity C-reactive protein(Baseline, 6 weeks, and 12 weeks)
- Omega-3 Index(Baseline, 6 weeks, and 12 weeks)