PDF(Pubmed)
Abstract：
BACKGROUND: The cornerstone in the management of type 2 diabetes (T2D) is lifestyle modification including a healthy diet, typically one in which carbohydrate provides 45%-60% of total energy intake (E%). Nevertheless, systematic reviews and meta-analyses of trials with low carbohydrate diets (which are increased in protein and/or fat) for T2D have found improved glycaemic control in the first months relative to comparator diets with higher carbohydrate content. Studies lasting ≥1 year are inconclusive, which could be due to decreased long-term dietary adherence. We hypothesise that glucometabolic benefits can be achieved following 12 months of carbohydrate-restricted dieting, by maximising dietary adherence through delivery of meal kits, containing fresh, high-quality ingredients for breakfast, dinner and snacks, combined with nutrition education and counselling.
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.
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.
摘要：
背景：2型糖尿病（T2D）管理的基石是改变生活方式，包括健康饮食，通常是碳水化合物提供总能量摄入的45%-60%(E%)。然而，对T2D低碳水化合物饮食(蛋白质和/或脂肪增加)试验的系统评价和荟萃分析发现,与碳水化合物含量较高的对照饮食相比,前几个月的血糖控制有所改善.持续≥1年的研究尚无定论，这可能是由于长期饮食依从性下降。我们假设糖代谢益处可以在限制碳水化合物节食12个月后实现。通过提供餐包来最大化饮食依从性，含有新鲜的，早餐的优质食材,晚餐和小吃，结合营养教育和咨询。
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。
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。
