Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark
Department of Clinical Nutrition, College of Applied Medical Sciences, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
BMJ Open. 2022 Mar 29;12(3):e051285. doi: 10.1136/bmjopen-2021-051285.
Personalised nutrition holds immense potential over conventional one-size-fits-all approaches for preventing and treating diet-related diseases, such as obesity. The current study aims to examine whether a personalised nutritional plan produces more favourable health outcomes than a standard approach based on general dietary recommendations in subjects with overweight or obesity and elevated waist circumference.
This project is a 10-week parallel, double-blinded randomised intervention trial. We plan to include 100 adults aged 18-65 years interested in losing weight, with body mass index ≥27 but<40 kg/m and elevated waist circumference (males >94 cm; females >80 cm). Participants will be categorised into one of five predefined 'clusters' based on their individual metabolic biomarker profile and genetic background, and will be randomised in a 1:1 ratio to one of two groups: (1) personalised plan group that will receive cluster-specific meals every day for 6 days a week, in conjunction with a personalised behavioural change programme via electronic push notifications; or (2) control group that will receive meals following the general dietary recommendations in conjunction with generic health behaviour prompts. The primary outcome is the difference between groups (personalised vs control) in the change in fat mass from baseline. Secondary outcomes include changes in weight and body composition, fasting blood glucose and insulin, lipid profile, adipokines, inflammatory biomarkers, and blood pressure. Other outcomes involve measures of physical activity and sleep patterns, health-related quality of life, dietary intake, eating behaviour, and biomarkers of food intake. The effect of the intervention on the primary outcome will be analysed by means of linear mixed models.
The protocol has been approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark. Study findings will be disseminated through peer-reviewed publications, conference presentations and media outlets.
NCT04590989.
个性化营养在预防和治疗与饮食相关的疾病（如肥胖症）方面，相较于传统的一刀切方法，具有巨大的潜力。本研究旨在检验在超重或肥胖且腰围升高的受试者中，与基于一般饮食建议的标准方法相比，个性化营养计划是否会产生更有利的健康结果。
这是一项为期 10 周的平行、双盲随机干预试验。我们计划纳入 100 名年龄在 18-65 岁之间、有减肥意愿的成年人，其体重指数（BMI）≥27 但<40 kg/m2 且腰围升高（男性>94 cm；女性>80 cm）。参与者将根据其个体代谢生物标志物谱和遗传背景，分为五个预先设定的“聚类”之一，并按照 1:1 的比例随机分为两组之一：（1）个性化计划组，每天将收到 6 天的特定于聚类的膳食，并通过电子推送通知收到个性化行为改变计划；或（2）对照组，将收到符合一般饮食建议的膳食，并结合一般健康行为提示。主要结局是基线时两组（个性化与对照组）体脂量变化的差异。次要结局包括体重和身体成分、空腹血糖和胰岛素、血脂谱、脂肪因子、炎症生物标志物和血压的变化。其他结局包括体力活动和睡眠模式、健康相关生活质量、饮食摄入、饮食行为以及食物摄入的生物标志物的测量。干预对主要结局的影响将通过线性混合模型进行分析。
该方案已获得丹麦哥本哈根首都大区伦理委员会的批准。研究结果将通过同行评议的出版物、会议演讲和媒体渠道进行传播。
NCT04590989。
