NCT07052344招募中不适用
Gut-Brain Neural Coupling in Spinal Cord Injury
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Phase amplitude coupling (PAC) strength
研究概览
简要总结
The purpose of this research is to determine the effects of food on brain and stomach activity in persons with and without spinal cord injury (SCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •, SCI and Controls
- •Adults, 18 to 70 years of age.
- •Sex, male or female.
- •Weight-stable (±3 kg) for the preceding 3 months (self-report).
- •Physically inactive adults not meeting weekly activity guidelines (<150 min/week) for the preceding 3 months (self-report).
- •Fluent in written and spoken English.
排除标准
- •, SCI and Controls
- •Do not meet the inclusion criteria.
- •Current/regular smoker (defined by Center for Disease Control (CDC)/ National Institute of Health (NIH) as an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes either every day or every other day) (self-report).
- •Currently dieting and/or trying to gain or lose weight.
- •Vagus or recurrent laryngeal nerve injury (self-report).
- •Uncontrolled thyroid disease, such that they are not on thyroid medication (e.g., levothyroxine) to treat the condition (self-report)
- •Diabetes (type 1 or type 2) and/or currently taking anti-diabetic or glucagon-like peptide-1 (GLP-1)/dual agonist medications (self-report).
- •Gastrointestinal disease (self-report), such as inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease, irritable bowel syndrome, gastroesophageal reflux disease, peptic ulcer disease, chronic pancreatitis, liver cirrhosis, and any condition requiring gastrointestinal surgery (e.g., bowel resection, colostomy, or ileostomy).
- •Swallowing disorder (self-report).
- •History of bariatric surgery
- •Food allergies/dislikes or dietary restrictions (i.e. vegan) (self-report).
- •Allergy to adhesives (self-report)
- •Open abdominal wounds or abdominal skin not intact.
- •Current use of probiotics/prebiotics (self-report).
- •Current use of medications that can impact appetite, body weight, and/or bowel function, such as prokinetic, antiemetic, narcotic analgesics, anticholinergic, anti-inflammatory, antipsychotic, or anti-obesity agents (self-report).
- •Pregnant (determined by urine pregnancy test) or breastfeeding women.
- •Non-adults (infants, children, teenagers).
- •Adults unable to consent
- •Prisoner.
- •SCI-specific Eligibility Criteria
- •Inclusion Criteria, SCI Only
- •At least 12 months post-SCI, denoting chronic injury
- •Complete American Spinal Injury Association (ASIA) Impairment Scale (AIS A) or motor-incomplete (AIS B) tetraplegia (SCI at or above C8 lesion)
- •Able to self-feed (self-report)
- •On a bowel care program every day or every other day (self-report).
- •Exclusion Criteria, SCI Only
- •Under 12 months post-SCI.
- •Motor-incomplete (AIS C, D) paraplegia (SCI below C8 lesion), including thoracic, lumbar, and sacral injuries.
- •Ventilator-dependence (self-report).
研究组 & 干预措施
Pre-load Condition Meal Group
Experimental
Participants will be in this group for up to 2 weeks.
干预措施: Preload condition (Other)
Pre-load Condition Meal Group
Experimental
Participants will be in this group for up to 2 weeks.
干预措施: Ad-libitum control condition (Other)
Ad-libitum Condition Meal Group
Active Comparator
Participants will be in this group for up to 2 weeks.
干预措施: Ad-libitum control condition (Other)
结局指标
主要结局
Phase amplitude coupling (PAC) strength
时间窗: up to 2 weeks
Gut-brain connectivity will be assessed using phase-amplitude coupling (PAC) to examine the interaction between gastric electrical oscillations and cortical rhythms. PAC will be calculated from electrophysiological raw data to produce one unitless value ranging from -1 to 1, for each subject. The higher the value, the greater the gut-brain connectivity/PAC strength.
次要结局
未报告次要终点
研究者
Gary Farkas
Assistant Professor
University of Miami
研究点 (2)
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