THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Optimal Phase 1b Dose
研究概览
简要总结
The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."
详细描述
The OMEGA-SPM-DOSE trial and the OMEGA-SPM-PAD trial are two parts of a pilot study which aims to investigate the effect of a novel formulation of a nutritional supplement containing highly concentrated n-3 PUFA metabolites (SPM Emulsion) on the metabolo-lipidomic profile of healthy volunteers and patients with Peripheral Arterial Disease(PAD). Ten healthy volunteers and ten patients with PAD will participate in Part 1a, the "OMEGA-SPM-DOSE Study". A follow-up, placebo controlled, prospective study on the best dosing modality determined in Phase 1a will then take place in a PAD and OA population (n=12), Phase 1b - the "OMEGA-SPM-PAD Study". Specific measurements will include targeted metabolo-lipidomic profiling, established markers of inflammation, and functional monocyte and macrophage assays. The proposed studies have the potential to provide important new insights on the role of nutritional interventions in PAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers:
- •PAD Patients:
- •Mild claudication to rest pain (Rutherford 1-4)
- •Resting or exercise ABI < 0.9 or TBI < 0.6
- •Age 40 and more
- •OA Patients:
- •Lower extremity (hip or knee) OA
排除标准
- •PAD, OA Patients and Healthy Volunteers:
- •Plan to undergo surgical procedure or PVI for treatment of PAD within one month
- •Evidence of active infection
- •Hypersensitivity or allergy to fish or seafood
- •Already on n-3 PUFA or equivalent
- •Chronic liver disease, end-stage renal disease (CKD 5), or chronic inflammatory disorders
- •Poorly controlled diabetes (HbA1C > 8%)
- •BMI < 20 or >35
- •Recent other major surgery or illness within 30 days
- •Use of immunosuppressive medications or steroids
- •History of organ transplantation
- •Pregnancy, or plans to become pregnant, or lactating
- •Healthy Volunteers:
- •hsCRP > 2mg/L
- •Regular aspirin use
- •Regular non-steroidal anti-inflammatory drug use
结局指标
主要结局
Optimal Phase 1b Dose
时间窗: Baseline, Day 33
The smallest dose administered in Phase 1a participants which results in an increase in Resolution Index at least 3 times that of baseline, or the subsequent larger dose resulting in a Resolution Index greater than 2 times that of the preceding does with no increase in side effects at the larger dose.
Change in the Resolution Index
时间窗: Baseline, Day 5
Integrated metabolo-lipidomics assessment of SPM pathways: Average concentration of 15-HEPE, 18-HEPE, 4-HDHA, and 17-HDHA in plasma.
次要结局
未报告次要终点