Department of Cellular and Molecular Nutrition, School of Nutritional Science and Dietetics, Tehran University of Medical Sciences, Tehran, 14155-6447, Iran.
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Trials. 2021 Sep 30;22(1):673. doi: 10.1186/s13063-021-05612-y.
Metabolic syndrome is a combination of metabolic risk factors causing a pathological condition that increases the risk of non-communicable diseases, such as diabetes and cardiovascular diseases. A variety of dietary approaches have been examined to halt this rapid trend; however, the effects of modified-Paleo diet and medium-carbohydrate diet on inflammation, adipokines, hepatokines, and the profile of endothelial microparticles in individuals with metabolic syndrome have not been investigated in detail. The present study is designed to examine the effect of modified-Paleo and moderate-carbohydrate diet with two delivery modes: "fixed diet plan" vs "calorie counting" on weight, body composition, serum levels of some hepatokines and adipocytokines, and flow cytometric analysis of endothelial microparticles in adults with metabolic syndrome.
Eighty metabolic syndrome patients will be recruited in this study. They will be randomly allocated to one of the following 4 groups: (1) receiving a modified-Paleo diet with calorie counting, (2) receiving a modified-Paleo diet with a fixed diet plan, (3) receiving a medium-carbohydrate diet with calorie counting, and (4) receiving a medium-carbohydrate diet with a fixed diet plan for 10 weeks. Weight, height, waist circumference, and body composition will be assessed at the study baseline and at the end of the trial. Serum insulin, asprosin, chemerin, FGF-21, CTRP-1, PYY, ghrelin, plasma EMPs (CD31+/CD42b- and CD144+/CD42b-), lipid profile, glycemic indices, hs-CRP, leptin, vitamin C, creatinine and satiety, hunger, fullness, and desire to eat (via visual analog scales) will be measured at the study baseline and at the end of the trial. Insulin resistance and insulin sensitivity will be determined using the HOMA-IR and QUICKI equations.
To the best of our knowledge, this is the first randomized controlled trial that will determine the effect of modified-Paleo and moderate-carbohydrate diet on weight, body composition, serum levels of some hepatokines and adipocytokines, and the profile of EMPs in adults with metabolic syndrome. Moreover, the effects of different diet delivery modes, including "fixed diet plan" and "calorie counting" will also be analyzed. The results of this trial can provide clinical witnesses on the effectiveness of carbohydrate-restricted diets in ameliorating metabolic status and prevent the development of chronic diseases.
Iranian Registry of Clinical Trials IRCT2016121925267N4 . Registered on 26 July 2017.
代谢综合征是一组代谢危险因素的组合，导致病理状况增加非传染性疾病的风险，如糖尿病和心血管疾病。已经研究了各种饮食方法来阻止这种快速趋势;然而，改良古食谱和中等碳水化合物饮食对炎症、脂肪因子、肝脏因子和代谢综合征个体内皮微颗粒特征的影响尚未详细研究。本研究旨在研究改良古食谱和中等碳水化合物饮食在两种输送模式下对体重、身体成分、一些肝脏因子和脂肪因子血清水平以及代谢综合征成年人内皮微颗粒的流式细胞分析的影响：“固定饮食计划”与“计算卡路里”。
本研究将招募 80 名代谢综合征患者。他们将被随机分配到以下 4 组之一：（1）接受计算卡路里的改良古食谱，（2）接受固定饮食计划的改良古食谱，（3）接受计算卡路里的中等碳水化合物饮食，（4）接受固定饮食计划的中等碳水化合物饮食，为期 10 周。在研究基线和试验结束时评估体重、身高、腰围和身体成分。在研究基线和试验结束时测量血清胰岛素、asporsin、chemerin、FGF-21、CTRP-1、PYY、ghrelin、血浆 EMPs（CD31+/CD42b-和 CD144+/CD42b-）、血脂谱、血糖指数、hs-CRP、瘦素、维生素 C、肌酐和饱腹感、饥饿感、饱腹感和食欲（通过视觉模拟量表）。使用 HOMA-IR 和 QUICKI 方程测定胰岛素抵抗和胰岛素敏感性。
据我们所知，这是第一项随机对照试验，旨在确定改良古食谱和中等碳水化合物饮食对代谢综合征成年人体重、身体成分、一些肝脏因子和脂肪因子血清水平以及 EMP 谱的影响。此外，还将分析不同饮食输送模式的效果，包括“固定饮食计划”和“计算卡路里”。该试验的结果可以为碳水化合物限制饮食在改善代谢状态和预防慢性病发展方面的有效性提供临床证据。
伊朗临床试验注册处 IRCT2016121925267N4。注册于 2017 年 7 月 26 日。
