Asia Pacific journal of clinical nutrition · 2026
Dietary inflammatory index and unfavorable dietary patterns associated with ischemic stroke in China.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыEquivalence TrialНазвание и аннотация: Перевод в очереди
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Yu Jianchun, Chen Wei, Xiao Gang, An Qi, Li Ziyu, Liang Bin, Li Yuanxin, Zhao Dongbing, Peng Junsheng, Zhou Yanbing, Lin Guole, Kang Weiming, Li Zijian, Yan Chao, Lin Yuanpei, Zhu Changzhen, Ren Hu, Lin Yijia, Tian Yulong
Аннотация
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.
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.