Dietary inflammatory index and unfavorable dietary patterns associated with ischemic stroke in China.
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: PubMed
Authors: Jianchun Yu, Wei Chen, Gang Xiao, Qi An, Ziyu Li, Bin Liang, Yuanxin Li, Dongbing Zhao, Junsheng Peng, Yanbing Zhou, Guole Lin, Weiming Kang, Zijian Li, Chao Yan, Yuanpei Lin, Changzhen Zhu, Hu Ren, Yijia Lin, Yulong Tian
Institutions: Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital, Beijing Hospital, Peking University Cancer Hospital, Peking University People's Hospital, Beijing Tsinghua Chang Gung Hospital, Tsinghua University, Cancer Hospital of Chinese Academy of Medical Sciences, Sun Yat-sen University, Sixth Affiliated Hospital of Sun Yat-sen University, Affiliated Hospital of Qingdao University
Language: English
Topic: Nutritional Studies and Diet
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7163665127