Liu Yupeng, Jiang Huinan, Ruan Binye, Liu Yi, Le Siyu, Fu Xiaoyi, Wang Shuran
Department of Epidemiology and Biostatistics, School of Public Health and Management, Wenzhou Medical University, Wenzhou, China.
Department of Nutrition and Food Hygiene, School of Public Health and Management, Wenzhou Medical University, Wenzhou, China.
Front Nutr. 2022 Jul 19;9:925870. doi: 10.3389/fnut.2022.925870. eCollection 2022.
China has the largest number of patients with Type 2 Diabetes Mellitus (T2DM), and it tends to increasingly grow in the future, putting an enormous burden on disease control and prevention in China. While glycemic variability (GV) came to be an important indicator of blood glucose control in diabetic patients, studies suggested that premeal snacks may help blood glucose control, but there are still some problems to be researched. Therefore, we designed this trial to evaluate which kind of premeal snacks would lead to better effects on GV under two diet patterns in pre-diabetes subjects and to evaluate assessments of acceptability and compliance, behavior, and metabolism changes in individuals will be described.
The study is a single-center, open-label, multiparallel group, randomized controlled trial. A total of 32 male and female volunteers will be randomized into 4 groups in a single allocated ratio of soy milk (powder) snack, milk (powder) snack, almonds snack, and placebo control with 250 ml of water taken 30 min before lunch, respectively. The study consists of two intervention periods over 11 days. The first intervention period under habitual diet conditions from D3 to D6 (4 days), during which all subjects are asked to maintain their habitual eating and daily activities similar to the run-in period. The second intervention consists of prelunch snacks with standard meals. We will examine both the effect of GV and various metabolic and behavioral outcomes potentially associated with the interventions. At the end of this study, we will assess the acceptability and maintainability of the intervention through interviews.
Chinese Clinical Trial Registry, identifier ChiCTR2200058935.
中国是2型糖尿病（T2DM）患者数量最多的国家，且未来有持续增长的趋势，这给中国的疾病防控带来了巨大负担。虽然血糖变异性（GV）已成为糖尿病患者血糖控制的重要指标，但研究表明，餐前进食零食可能有助于血糖控制，但仍有一些问题有待研究。因此，我们设计了本试验，以评估在两种饮食模式下，哪种餐前进食零食对糖尿病前期受试者的GV影响更佳，并评估可接受性、依从性、行为及个体代谢变化的情况。
本研究为单中心、开放标签、多平行组随机对照试验。总共32名男女志愿者将按1:1:1:1的比例随机分为4组，分别为豆浆（粉）零食组、牛奶（粉）零食组、杏仁零食组和安慰剂对照组，每组在午餐前30分钟分别饮用250毫升相应饮品。本研究包括两个为期11天的干预期。第一个干预期在D3至D6（4天）的习惯饮食条件下进行，在此期间，要求所有受试者保持与导入期相似的饮食习惯和日常活动。第二个干预期包括标准餐搭配餐前进食零食。我们将研究GV的影响以及与干预措施可能相关的各种代谢和行为结果。在本研究结束时，我们将通过访谈评估干预措施的可接受性和可持续性。
中国临床试验注册中心，标识符ChiCTR2200058935。
