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Идёт набор NCT07052344

Gut-Brain Neural Coupling in Spinal Cord Injury

Без фазы С лечением SCI - Spinal Cord Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Preload condition, Ad-libitum control condition.
Кому может быть актуально
Состояния в реестре: SCI - Spinal Cord Injury. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Вмешательства

  • Другое Preload condition
    Participants will consume a fixed compulsory preload meal of Campbell's Tomato soup (\~300 grams) 30 minutes after the baseline assessments. Fifteen minutes after consuming the preload meal, participants will receive the ad libitum test meal, consisting of a pre-weighed serving of Stouffer's Macaroni and Cheese (\~700 g).The pre-load condition will be completed at only one of two visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. Duration for the pre-load con
  • Другое Ad-libitum control condition
    Participants will only consume the ad libitum test meal, which consists of a pre-weighted serving of Stouffer's Macaroni and Cheese (\~700 g). The ad-libitum meal will be consumed at both visits. Participation will be up to 2 weeks with the visits separated by up to 2 weeks. The ad-libitum control condition visit will take up to 2 hours.

Первичные конечные точки

  • Phase amplitude coupling (PAC) strength [Срок оценки: up to 2 weeks]

Критерии участия

Inclusion Criteria, 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.

Exclusion Criteria, 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Miami - Miami Project to Cure Paralysis — Miami

Идентификаторы

NCT: NCT07052344 · 20250237

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗