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Ensayo controlado aleatorizado2026Financiado por la industria

Financiado en parte por Abbott Laboratories Trading (Shanghai) Co., Ltd

Dietary inflammatory index and unfavorable dietary patterns associated with ischemic stroke in China

Yu J, Chen W, Xiao G, An Q, Li Z, Liang B, Li Y, Zhao D, Peng J, Zhou Y, Lin G, Kang W, Li Z, Yan C, Lin Y, Zhu C, Ren H, Lin Y, Tian Y

Asia Pacific journal of clinical nutrition · 0 citas

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Financiado por la industria

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Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiado por la industria
Empresa
Abbott Laboratories Trading (Shanghai) Co., Ltd

Según 1 financiador declarado.

Publicación

Publicado
2026-06-01 · Asia Pac J Clin Nutr · vol. 35 · número 3 · págs. 463–474
Editorial
National Institutes of Health
Citado
0 citas · más que el 40% de estudios similares · 0.0× el promedio de su campo
Referencias
0 trabajos
Acceso
Acceso abierto (copia en repositorio)
Áreas de investigación
Nutritional Studies and Diet · Fatty Acid Research and Health · Clinical Nutrition and Gastroenterology
Palabras clave
Dietary Inflammatory Index, ischemic stroke, dietary habits, perioperative nutrition, gastrointestinal cancer, prealbumin, serum triglycerides, enteral nutrition, malnutrition
MeSH
humans, gastrointestinal neoplasms, malnutrition, inflammation, fish oils, enteral nutrition, diet, nutritional status, aged, middle aged, china, female, male, stroke

19 autores

  • Jianchun Yu🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Peking Union Medical College Hospital
  • W X Chen🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Peking Union Medical College Hospital
  • Gang Xiao🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Hospital
  • Qi An🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Hospital
  • Ziyu Li🇨🇳Peking University Cancer Hospital
  • Bin Liang🇨🇳Peking University People's Hospital
  • Yuanxin Li🇨🇳Beijing Tsinghua Chang Gung Hospital; Tsinghua University
  • Dongbing Zhao🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Cancer Hospital of Chinese Academy of Medical Sciences
  • J S Peng🇨🇳Sun Yat-sen University; Sixth Affiliated Hospital of Sun Yat-sen University
  • Y B Zhou🇨🇳Affiliated Hospital of Qingdao University
  • Guole Lin🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Peking Union Medical College Hospital
  • Weiming Kang🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Peking Union Medical College Hospital
  • Zijian Li🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Hospital
  • Chao Yan🇨🇳Peking University Cancer Hospital
  • Yuanpei Lin🇨🇳Peking University People's Hospital
  • Changzhen Zhu🇨🇳Beijing Tsinghua Chang Gung Hospital; Tsinghua University
  • Hu Ren🇨🇳Chinese Academy of Medical Sciences & Peking Union Medical College; Cancer Hospital of Chinese Academy of Medical Sciences
  • Yuxin Lin🇨🇳Sun Yat-sen University; Sixth Affiliated Hospital of Sun Yat-sen University
  • Yulong Tian🇨🇳Affiliated Hospital of Qingdao University

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background and objectives

This study aimed to evaluate the safety and efficacy of a fish oil-enriched food for special medical purposes (FSMP, ProSure) compared to an oncology-specific enteral nutrition product (TPF-T).

Methods and study design

This multicenter, randomized, open-label, non-inferiority phase III trial (NCT05301556) included patients with gastrointestinal tumors scheduled for surgery and at high risk for malnutrition. Participants were randomized 1:1 to receive either FSMP or TPF-T as a sole nutritional source from 4±2 days before surgery to 9±3 days postoperatively. The primary endpoint was the change in serum pre-albumin levels from baseline to 9±3 days post-surgery (non-inferiority margin: 20.807 mg/L).

Results

Of the 325 patients randomized (FSMP: n = 162; TPF-T: n = 163), FSMP demonstrated non-inferiority to TPF-T in maintaining serum pre-albumin levels in the perioperative patients (least square [LS] mean differ-ence: 6.9 mg/L, 95% CI: -5.0 to 18.8). FSMP showed a greater reduction in serum triglycerides (LS mean difference: -0.133 mmol/L, 95% CI: -0.239 to -0.027, p = 0.014), while comparable changes in other lipid parameters, serum albumin, body weight, or grip strength from baseline to 9±3 days post-surgery, and the length of hospital stay were observed between groups (all p >0.05). The most common treatment-emergent adverse events were gastrointestinal disorders, including abdominal distension (FSMP: 17.3% vs. TPF-T: 18.4%), di-arrhea (21.0% vs. 11.0%), and nausea (6.8% vs. 5.5%).

Conclusions

ProSure, an FSMP, when used as a sole nutritional source, is not inferior to TPF-T in maintaining perioperative nutritional status in patients with gastrointestinal tumors, demonstrating comparable efficacy and safety.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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