Physiological and Behavioral Regulation of Feeding After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Gastric emptying time
研究概览
简要总结
The overall purpose of this research is to understand the reasons why persons with spinal cord injuries eat more calories than they need to "burn", stay alive, and function. This research will investigate how quickly food moves through a participant's body, the hormones in the participant's body that control energy and digestion, and a participant's impressions of hunger after eating a meal. This will be compared in persons with and without a spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Spinal Cord Injury (SCI) Participants:
- •Adults (≥ 18 years) with tetraplegia (C5-C8) or paraplegia (T1-L2) SCI
- •Chronic SCI, denoted as ≥ 12 months post-injury
- •American Spinal Injury Association Impairment Scale164 A, B, and C
- •Persons with tetraplegia self-report they are able to feed themselves
- •Self-report on a bowel care program every-other-day
- •English speaking
- •Control Group (Healthy) Participants:
- •Adults (≥ 18 years) without a SCI (will be sex- and age-matched to persons with SCI)
- •English speaking
排除标准
- •For All Participants:
- •Currently on a weight loss program/diet and/or actively trying to lose weight
- •Have a self-reported history of
- •Thyroid disease
- •Gastrointestinal disease
- •Previous abdominal surgery ≤ 3 months prior to the study
- •Peripheral nervous system prosthesis
- •Swallowing disorders
- •Self-reported food allergies to or dislike the test meals.
- •Self-reported use of a prokinetic agent, antipsychotic agent, or Glucagon like Peptide 1 (GLP-1) agonists
- •Individuals who are not yet adults (infants, children, teenagers)
- •Women that self-report they are pregnant or likely to become pregnant
结局指标
主要结局
Gastric emptying time
时间窗: Up to seven days
Gastric emptying will be measured by the SmartPill Wireless Motility Capsule
Upper gastrointestinal transit time
时间窗: Up to seven days
Upper gastrointestinal transit time will be measured by the SmartPill Wireless Motility Capsule
次要结局
- Change in postprandial peptide tyrosine tyrosine (PYY)(Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).)
- Change in postprandial Glucagon Peptide 1 (GLP-1)(Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).)
- Change in postprandial ghrelin(Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).)
- Change in postprandial cholecystokinin (CKK)(Before the second test meal (up to 7 days) and up to 120 minutes after the second test meal (up to 7 days).)
- Change in subjective appetite rating as measured by Palatability Series Visual Analogue Scale(Baseline and up to 7 days)
- Change in subjective appetite rating as measured by Hunger Series Visual Analogue Scale(Baseline and up to 7 days)
- Total percentage body fat(Baseline)
研究者
Gary Farkas
Postdoctoral Associate
University of Miami