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 difference: 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%), diarrhea (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.
This erratum corrects the academic qualifications of the authors of the article DOI: 10.6133/apjcn.202604_35(2).0007 The correct academic qualifications of the authors are: Pengfeng Qu MSc, Yingying Jiao MSc, Liusen Wang MSc, Weiyi Li MPH, Hongru Jiang MPH, Jiguo Zhang PhD, Huijun Wang MSc, Bing Zhang PhD, Junhua Han PhD, Aidong Liu PhD, Zhihong Wang PhD The authors regret this error. This correction does not affect the scientific content, results, or conclusions of the article.
BACKGROUND AND OBJECTIVES:Early-life diet may influence immune development and the risk of allergic diseases. This study investigated associations between dietary patterns at 24 months of age and allergic diseases in Korean toddlers. METHODS AND STUDY DESIGN:In this cross-sectional study, 433 toddlers from the Korean Mothers and Children's Environmental Health (MOCEH) cohort were included. Dietary intake was assessed using two non-consecutive 24-hour recalls. Factor analysis of 26 food groups identified dietary patterns, and individual pattern scores were categorized into tertiles based on ascending distribution. Allergic diseases were determined by caregiver questionnaires. Multivariable logistic regression was used to assess associations, adjusting for confounders. RESULTS:Three dietary patterns were identified: Pattern 1 (white rice, kimchi, and non-salt-preserved vegetables), Pattern 2 (seasoning, butter, and meat), and Pattern 3 (milk and dairy products). Compared with the lowest tertile, the highest tertile of Pattern 2 was associated with higher odds of other allergic diseases (OR: 7.55; 95% CI: 1.62-35.23), and any allergic disease (OR: 2.03; 95% CI: 1.10-3.73). Pattern 3 was inversely associated with atopic dermatitis (OR: 0.51; 95% CI: 0.27-0.98), while Pattern 1 showed no significant association. CONCLUSIONS:Early childhood dietary patterns may influence the development of allergic disease. A pattern characterized by seasoning, butter, and meat was associated with an increased risk of allergic disease, whereas a dairy-based pattern was inversely associated with atopic dermatitis in Korean toddlers.
BACKGROUND AND OBJECTIVES:The gestational weight gain (GWG) range during mid-to-late pregnancy associated with the lowest combined risk of adverse birth outcomes in women with gestational diabetes mellitus (GDM) remains unclear. This study aims to examine the associations between GWG and adverse birth out-comes among women with GDM. METHODS AND STUDY DESIGN:This study included a cohort of 1,673 pregnant women with GDM. GWG was defined as weight gain from pre-pregnancy to a measurement between 24 and 32 gestational weeks, residualized for gestational age and standardized as z-scores. Multivariable logistic regression models were used to assess associations between GWG z-scores (per 1-SD increase and categories: <-1, -1 to 1 [reference], and ≥1) and small for gestational age (SGA), large for gestational age (LGA), and preterm birth. Restricted cubic splines were fitted to explore nonlinear associations. RESULTS:Each 1-SD higher in GWG z-score was associated with lower odds of SGA (odds ratio [OR], 0.55; 95% confidence interval [CI], 0.43-0.71) and higher odds of LGA (1.48; 1.29-1.70). Compared with the reference group, women with GWG z-scores <-1 had higher odds of SGA and lower odds of LGA, whereas those with z-scores ≥1 showed the opposite pattern. No significant association was observed with preterm birth. Spline analyses indicated that a GWG z-score of approximately -0.07 (equal to 8.2 kg at 28 weeks) was associated with the lowest combined odds of SGA and LGA. CONCLUSIONS:Among women with GDM, both insufficient and excessive mid-to-late pregnancy GWG were associated with adverse size-for-gestational-age outcomes.
BACKGROUND AND OBJECTIVES:Vitamin D has been proposed to influence several cardiometabolic risk factors; however, evidence from randomized controlled trials (RCTs) and recent meta-analyses remains inconsistent regarding the magnitude of these effects. This meta-analysis evaluated the effects of vitamin D supplementation on lipid profile, blood pressure, and glycaemic parameters, and explored whether age and baseline serum vitamin D concentrations modified these associations. METHODS AND STUDY DESIGN:A systematic review and meta-analysis of RCTs was conducted to compare oral vitamin D supplementation with placebo in adults. PubMed, the Cochrane Library, and ClinicalTrials.gov were searched systematically. Risk of bias was as-sessed using the Cochrane risk-of-bias tool. Pooled effect sizes with 95% confidence intervals (CIs) were estimated using random-effects models. RESULTS:A total of 14,051 abstracts were identified, and 45 RCTs were included in the final analysis. Vitamin D supplementation significantly reduced low-density lipoprotein cho-lesterol (LDL-C) by 0.136 mmol/L (95% CI: -0.215, -0.056), systolic blood pressure (SBP) by 2.79 mm Hg (95% CI: -4.65, -0.94), fasting blood glucose (FBG) by 0.11 mmol/L (95% CI: -0.19, -0.04), and hemoglobin A1c (HbA1c) by 0.164% (95% CI: -0.32, -0.01) compared with placebo. Subgroup analyses showed reductions in SBP and LDL-C among participants aged ≥55 years, whereas FBG was reduced in those aged <55 years. While favorable effects on FBG and HbA1c were observed with a baseline blood level of vitamin D of less than 50 nmol/L. CONCLUSIONS:Vitamin D supplementation may modestly improve selected cardiomet-abolic risk factors. Age and baseline vitamin D status may influence these effects, although their clinical sig-nificance remains uncertain. Further well-designed RCTs are needed.
