Effects of a Preoperative Capsaicin-Containing Diet on Postoperative Liver Injury Repair: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether a capsaicin-containing diet started before surgery can reduce liver injury and help the liver recover in adults aged 18 to 75 years who are scheduled for surgery to remove part of the liver because of a liver mass. Capsaicin is the substance that makes chili peppers spicy. The study will also assess the safety and tolerability of this diet.
The main questions it aims to answer are:
Does the capsaicin-containing diet help blood levels of alanine aminotransferase (ALT), a marker of liver injury, fall more quickly between the first and fifth days after surgery?
Does it improve other measures of liver recovery and reduce liver failure after surgery?
What side effects, including stomach or intestinal discomfort, occur during the study?
Researchers will compare a jelly containing chili powder with a similar-looking placebo jelly containing sweet pepper powder without capsaicin. Both groups will receive the same standard care before, during, and after surgery.
The study plans to enroll 110 participants. Participants will be assigned by chance to one of the two groups, with an equal chance of receiving either study diet. Participants and the researchers assessing their recovery will not know which diet they receive.
Participants will:
Take the assigned jelly three times daily with meals, starting 2 days before surgery and continuing through the evening of the first day after surgery, with a pause for surgery as directed by the study team. The capsaicin group will receive approximately 7.5 mg of capsaicin per day.
Avoid other spicy foods while taking the study diet.
Have blood tests before and after surgery to assess liver injury, liver function, and safety.
Report any discomfort or other health problems to the study team.
Complete follow-up assessments around 30 and 90 days after surgery to check recovery, complications, hospital readmissions, and survival.
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Тип исследования
Тип исследования
Регистрация (Оцененный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
Контакты исследования
- Имя: Xinyu Zhan
- Номер телефона: 18163017789
- Электронная почта: zhanxinyu990618@163.com
Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age 18 to 75 years, of any sex.
A focal liver lesion scheduled for elective open or laparoscopic liver resection, such as hepatocellular carcinoma, colorectal liver metastases, or hepatic hemangioma.
Child-Pugh class A or B with a score of 7 or less, and indocyanine green retention at 15 minutes (ICG-R15) of 20% or less.
Planned intraoperative hepatic inflow occlusion.
An anticipated future liver remnant of at least 30% in patients with a normal liver or at least 40% in patients with cirrhosis.
Ability to tolerate an oral chili powder challenge, such as 0.5 g without gastrointestinal discomfort.
Willingness and ability to comply with the standardized study diet initiated 2 days before surgery, with a planned capsaicin dose of 7.5 mg/day in three divided doses with meals for participants assigned to the capsaicin group, and provision of written informed consent.
No severe cardiac, pulmonary, or renal dysfunction, with an estimated glomerular filtration rate (eGFR) of at least 60 mL/min.
No history of liver transplantation or other organ transplantation.
Exclusion Criteria:
- Pregnancy or breastfeeding.
A history of or current malignancy other than the disease for which liver resection is planned, unless cured for at least 5 years without recurrence. Hepatocellular carcinoma scheduled for resection, and colorectal liver metastases together with their corresponding colorectal primary cancer, are not excluded under this criterion.
Persistent preoperative elevation of transaminases or total bilirubin above twice the upper limit of normal that does not improve with treatment, or a white blood cell count below the lower limit of normal.
A requirement for a combined radical oncologic procedure, such as pancreaticoduodenectomy or radical resection for hilar cholangiocarcinoma.
Tumor thrombus in the main portal vein, the right or left portal vein branch, a hepatic vein, or the inferior vena cava.
Severe cirrhosis with a Child-Pugh score of 8 or higher, or moderate to severe esophagogastric varices identified by endoscopy.
Active bleeding, a coagulation disorder with an international normalized ratio (INR) greater than 1.5 or a platelet count below 100 × 10^9/L, or another contraindication to surgery.
Severe cardiac, pulmonary, or renal dysfunction, defined as New York Heart Association (NYHA) functional class III or IV, forced expiratory volume in 1 second (FEV1) below 50% of the predicted value, or eGFR below 60 mL/min.
A history of or current active peptic ulcer disease, severe gastritis, gastroesophageal reflux disease (GERD), or a known allergy to chili powder or capsaicin.
Severe infection, active tuberculosis, autoimmune hepatitis, or another acute or chronic systemic disease.
Participation in another interventional clinical trial or use of an investigational drug affecting liver function within the preceding 3 months.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
|
Экспериментальный: Capsaicin-Containing Diet
|
A food-based dietary intervention consisting of an oral jelly containing Thai chili powder. Each 15-mL serving contains 1.25 g of chili powder, providing approximately 2.5 mg of capsaicin. One serving is taken orally three times daily with meals, for a total of 3.75 g of chili powder and approximately 7.5 mg of capsaicin per day. Administration begins 2 days before surgery and continues through the evening of postoperative day 1, with perioperative interruption for surgery. Participants avoid other spicy foods during the intervention period. |
|
Плацебо Компаратор: Placebo Diet
|
An oral placebo jelly containing sweet pepper powder without capsaicin, matched to the capsaicin-containing jelly in appearance and caloric content. One serving is taken orally three times daily with meals, beginning 2 days before surgery and continuing through the evening of postoperative day 1, with perioperative interruption for surgery. Participants avoid other spicy foods during the intervention period. |
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postoperative Alanine Aminotransferase (ALT) Recovery Rate
Временное ограничение: From 24 to 120 hours after liver resection (postoperative days 1 to 5).
|
The postoperative ALT recovery rate is assessed using the decline in the natural logarithm of serum ALT between 24 and 120 hours after liver resection, expressed as a rate per 24 hours. Serum ALT is measured preoperatively and at 24 and 120 hours postoperatively. The preoperative measurement serves as the baseline reference. |
From 24 to 120 hours after liver resection (postoperative days 1 to 5).
|
Соавторы и исследователи
Спонсор
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Начало исследования
Первичное завершение (Оцененный)
Первичное завершение
Завершение исследования (Оцененный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- TJ-202512181
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .