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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Xinyu Zhan
- 电话号码:18163017789
- 邮箱:zhanxinyu990618@163.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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. |
|
安慰剂比较: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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Alanine Aminotransferase (ALT) Recovery Rate
大体时间: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).
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- TJ-202512181
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