Association Among Body Composition, Chronic Pain, Evoked Pain Sensitivity, and Adiposity-related Systemic Inflammation in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- peak change in Interleukin (IL)-6
研究概览
简要总结
The purposes of the study are to quantify and compare relationships among acute changes in inflammatory markers and evoked pain sensitivity after a high-fat meal (HFM) challenge, compared to a moderate-fat meal challenge, and explore the influence of body composition on these responses, in individuals with chronic spinal cord injury
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Spinal cord injury occurring at least 2 years prior to study entry
- •Neurological level of injury (LOI) between C4 and L2
- •American Spinal Injury Association Impairment Scale (AIS) A-D
- •English-speaking.
排除标准
- •Cognitive dysfunction that limits ability to adequately understand the risks of the study or are otherwise unable to consent
- •Health conditions associated with chronic systemic inflammation unrelated to weight or adiposity (e.g., systemic autoimmune diseases, recurrent or active urinary tract infection, pressure injury > Stage 2)
- •Conditions that preclude measurement of body composition by dual-energy x-ray absorptiometry (DXA; e.g., lower limb contracture > 15 degrees)
- •Inability to obtain free-flowing blood from a superficial forearm or hand vein
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Moderate Fat Meal, Followed by High Fat Meal Group
Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.
干预措施: Moderate Fat Meal (Other)
Moderate Fat Meal, Followed by High Fat Meal Group
Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.
干预措施: High Fat Meal (Other)
High Fat Meal, Followed by Moderate Fat Meal Group
Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.
干预措施: Moderate Fat Meal (Other)
High Fat Meal, Followed by Moderate Fat Meal Group
Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.
干预措施: High Fat Meal (Other)
结局指标
主要结局
peak change in Interleukin (IL)-6
时间窗: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
analysis of blood samples taken after ingestion of meal challenge for level of IL-6 in picograms/milliliter
peak change in evoked pain sensitivity
时间窗: at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion
measures of heat pain threshold (degrees Celsius), using the ascending method of limits via a 30mm2 surface thermode, obtained after ingestion of meal challenge
次要结局
- correlation coefficient between changes in IL-6 and evoked pain sensitivity(at 40, 80, 160, 240, 320, and 400 minutes post meal ingestion)
研究者
Elizabeth Felix
Research Professor
University of Miami