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Effects of a Preoperative Capsaicin-Containing Diet on Postoperative Liver Injury Repair: A Randomized Controlled Trial

4. november 2026 oppdatert av: Wan-Guang Zhang, Tongji Hospital

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Placebo komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Alanine Aminotransferase (ALT) Recovery Rate
Tidsramme: 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).

Samarbeidspartnere og etterforskere

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Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

4. november 2026

Først innsendt som oppfylte QC-kriteriene

4. november 2026

Først lagt ut (Faktiske)

9. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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