Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.
Department of Food Science, Aarhus University, Aarhus, Denmark.
BMJ Open. 2024 Aug 13;14(8):e084686. doi: 10.1136/bmjopen-2024-084686.
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.
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/m. 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.
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.
NCT05330247.
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.
2 型糖尿病（T2D）的治疗基石是生活方式的改变，包括健康饮食，通常碳水化合物提供总能量摄入（E%）的 45%-60%。然而，针对低碳水化合物饮食（增加蛋白质和/或脂肪）的临床试验进行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，在最初几个月内血糖控制得到改善。持续时间≥1 年的研究尚无定论，这可能是由于长期饮食依从性下降。我们假设通过提供包含早餐、晚餐和零食的新鲜、高质量成分的餐包，结合营养教育和咨询，最大限度地提高饮食依从性，在进行 12 个月的低碳水化合物饮食后，可以实现葡萄糖代谢获益。
本方案描述了一项为期 12 个月的由研究者发起的、随机对照、开放性、优效性试验，有两个平行组，将比较低碳水化合物高蛋白（CRHP）饮食与常规糖尿病（CD）饮食对 100 名 T2D 患者和 BMI>25kg/m2 的葡萄糖代谢控制（糖化血红蛋白变化为主要结局）的影响。参与者将按 1:1 随机分配接受 CRHP 或 CD 饮食（分别由碳水化合物提供 30/50 E%、蛋白质提供 30/17 E%和脂肪提供 40/33 E%），持续 12 个月，以餐包形式提供，包含涵盖参与者维持体重所需的三分之二以上估计每日能量需求的食物。注册临床营养师每月进行营养教育和咨询，以加强对分配饮食的依从性。
该试验已获得丹麦首都大区国家卫生研究伦理委员会的批准。该试验将按照《赫尔辛基宣言》进行。研究结果将提交国际同行评议的科学期刊发表。
NCT05330247。
该试验方案于 2022 年 3 月 9 日获得批准（研究编号：H-21057605）。本协议中描述的最新方案版本于 2023 年 6 月 23 日获得批准。
