Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg, Denmark; Department of Food Science, University of Copenhagen, Frederiksberg, Denmark.
Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.
Clin Nutr. 2022 Feb;41(2):441-451. doi: 10.1016/j.clnu.2021.12.031. Epub 2021 Dec 25.
BACKGROUND & AIMS: Intake assessment in multicenter trials is challenging, yet important for accurate outcome evaluation. The present study aimed to characterize a multicenter randomized controlled trial with a healthy Nordic diet (HND) compared to a Control diet (CD) by plasma and urine metabolic profiles and to associate them with cardiometabolic markers.
During 18-24 weeks of intervention, 200 participants with metabolic syndrome were advised at six centres to eat either HND (e.g. whole-grain products, berries, rapeseed oil, fish and low-fat dairy) or CD while being weight stable. Of these 166/159 completers delivered blood/urine samples. Metabolic profiles of fasting plasma and 24 h pooled urine were analysed to identify characteristic diet-related patterns. Principal components analysis (PCA) scores (i.e. PC1 and PC2 scores) were used to test their combined effect on blood glucose response (primary endpoint), serum lipoproteins, triglycerides, and inflammatory markers.
The profiles distinguished HND and CD with AUC of 0.96 ± 0.03 and 0.93 ± 0.02 for plasma and urine, respectively, with limited heterogeneity between centers, reflecting markers of key foods. Markers of fish, whole grain and polyunsaturated lipids characterized HND, while CD was reflected by lipids containing palmitoleic acid. The PC1 scores of plasma metabolites characterizing the intervention is associated with HDL (β = 0.05; 95% CI: 0.02, 0.08; P = 0.001) and triglycerides (β = -0.06; 95% CI: -0.09, -0.03; P < 0.001). PC2 scores were related with glucose metabolism (2 h Glucose, β = 0.1; 95% CI: 0.05, 0.15; P < 0.001), LDL (β = 0.06; 95% CI: 0.01, 0.1; P = 0.02) and triglycerides (β = 0.11; 95% CI: 0.06, 0.15; P < 0.001). For urine, the scores were related with LDL cholesterol.
Plasma and urine metabolite profiles from SYSDIET reflected good compliance with dietary recommendations across the region. The scores of metabolites characterizing the diets associated with outcomes related with cardio-metabolic risk. Our analysis therefore offers a novel way to approach a per protocol analysis with a balanced compliance assessment in larger multicentre dietary trials. The study was registered at clinicaltrials.gov with NCT00992641.
在多中心试验中，摄入评估具有挑战性，但对于准确的结果评估很重要。本研究旨在通过血浆和尿液代谢谱描述一项与健康的北欧饮食（HND）相比的多中心随机对照试验（与对照饮食[CD]相比），并将其与心脏代谢标志物相关联。
在 18-24 周的干预期间，200 名代谢综合征患者被建议在六个中心食用 HND（例如全谷物产品、浆果、菜籽油、鱼和低脂乳制品）或 CD ，同时保持体重稳定。其中 166/159 名完成者提供了血液/尿液样本。分析空腹血浆和 24 小时混合尿液的代谢谱，以确定与饮食相关的特征性模式。使用主成分分析（PCA）得分（即 PC1 和 PC2 得分）来检验它们对血糖反应（主要终点）、血清脂蛋白、甘油三酯和炎症标志物的综合影响。
该谱以 0.96 ± 0.03 和 0.93 ± 0.02 的 AUC 区分 HND 和 CD，分别为血浆和尿液，中心之间的异质性有限，反映了关键食物的标志物。鱼类、全谷物和多不饱和脂质的标志物表征了 HND，而 CD 则反映了含有棕榈油酸的脂质。反映干预措施的血浆代谢物的 PC1 得分与 HDL 相关（β=0.05；95%CI：0.02，0.08；P=0.001）和甘油三酯（β=-0.06；95%CI：-0.09，-0.03；P<0.001）。PC2 得分与葡萄糖代谢（2 小时血糖，β=0.1；95%CI：0.05，0.15；P<0.001）、LDL（β=0.06；95%CI：0.01，0.1；P=0.02）和甘油三酯（β=0.11；95%CI：0.06，0.15；P<0.001）有关。对于尿液，得分与 LDL 胆固醇有关。
SYSDIET 的血浆和尿液代谢产物反映了该地区对饮食建议的良好依从性。饮食特征代谢物的得分与与心脏代谢风险相关的结果相关。因此，我们的分析为在更大的多中心饮食试验中进行基于方案的分析和平衡依从性评估提供了一种新方法。该研究在 clinicaltrials.gov 上注册，编号为 NCT00992641。
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