METHODS: This protocol describes a 12-month investigator-initiated randomised controlled, open-label, superiority trial with two parallel groups that will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared with a conventional diabetes (CD) diet on glucometabolic control (change in glycated haemoglobin being the primary outcome) in 100 individuals with T2D and body mass index (BMI) >25 kg/m2. Participants will be randomised 1:1 to receive either the CRHP or the CD diet (comprised 30/50 E% from carbohydrate, 30/17 E% from protein and 40/33 E% from fat, respectively) for 12 months delivered as meal kits, containing foods covering more than two-thirds of the participants\' estimated daily energy requirements for weight maintenance. Adherence to the allocated diets will be reinforced by monthly sessions of nutrition education and counselling from registered clinical dietitians.
BACKGROUND: The trial has been approved by the National Committee on Health Research Ethics of the Capital Region of Denmark. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be submitted for publication in international peer-reviewed scientific journals.
BACKGROUND: NCT05330247.
METHODS: The trial protocol was approved on 9 March 2022 (study number: H-21057605). The latest version of the protocol, described in this manuscript, was approved on 23 June 2023.
方法:本方案描述了一项为期12个月的研究者启动的随机对照研究,开放标签,在两个平行组进行的优势试验中,将在100名T2D和体重指数(BMI)>25kg/m2的个体中,研究与常规糖尿病(CD)饮食相比,减少碳水化合物高蛋白(CRHP)饮食对糖代谢控制(主要结局为糖化血红蛋白的变化)的影响.参与者将被随机分为1:1,以接受CRHP或CD饮食(包含30/50E%的碳水化合物,30/17E%来自蛋白质,40/33E%来自脂肪,分别)作为餐包交付12个月,含有超过三分之二的参与者的食物,估计每天维持体重所需的能量。通过注册临床营养师每月的营养教育和咨询会议,将加强对分配饮食的遵守。
背景:该试验已获得丹麦首都地区国家卫生研究伦理委员会的批准。审判将根据赫尔辛基宣言进行。结果将提交国际同行评审的科学期刊上发表。
背景:NCT05330247。
方法:试验方案于2022年3月9日获得批准(研究编号:H-21057605)。协议的最新版本,在这份手稿中描述,2023年6月23日批准。