Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, 20133 Milan, Italy.
Center of Obesity and Work EASO Collaborating Centers for Obesity Management, Occupational Health Unit, Fondazione Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.
Nutrients. 2021 May 26;13(6):1804. doi: 10.3390/nu13061804.
The prevention and treatment of obesity and its cardio-metabolic complications are relevant issues worldwide. Among lifestyle approaches, very low-calorie ketogenic diets (VLCKD) have been shown to lead to rapid initial weight loss, resulting in better long-term weight loss maintenance. As no information on VLCKD studies carried on in a real-world setting are available, we conducted this multi-centre study in a real-world setting, aiming at assessing the efficacy and the safety of a specific multiphasic VLCKD program in women with overweight or obesity.
A multi-center, prospective, uncontrolled trial was conducted in 33 outpatient women (age range 27-60 y) with overweight or obesity (BMI: 30.9 ± 2.7 kg/m; waist circumference: 96.0 ± 9.4 cm) who started a VLCKD dietary program (duration: 24 weeks), divided into four phases. The efficacy of VLCKD was assessed by evaluating anthropometric measures and cardiometabolic markers; liver and kidney function biomarkers were assessed as safety parameters.
The VLCKD program resulted in a significant decrease of body weight and BMI (-14.6%) and waist circumference (-12.4%). At the end of the protocol, 33.3% of the participants reached a normal weight and the subjects in the obesity range were reduced from 70% to 16.7%. HOMA-IR was markedly reduced from 3.17 ± 2.67 to 1.73 ± 1.23 already after phase 2 and was unchanged thereafter. Systolic blood pressure decreased after phase 1 (-3.5 mmHg) and remained unchanged until the end of the program. Total and LDL cholesterol and triglycerides were significantly reduced by VLCKD along with a significant HDL cholesterol increase. Liver, kidney and thyroid function markers did not change and remained within the reference range.
The findings of a multi-center VLCKD program conducted in a real-world setting in a cohort of overweight/obese women indicate that it is safe and effective, as it results in a major improvement of cardiometabolic parameters, thus leading to benefits that span well beyond the mere body weight/adiposity reduction.
肥胖及其代谢并发症的预防和治疗是全球范围内的相关问题。在生活方式方法中,极低碳水化合物生酮饮食(VLCKD)已被证明可导致快速初始体重减轻,从而实现更好的长期体重减轻维持。由于没有关于真实环境中 VLCKD 研究的信息,我们在真实环境中进行了这项多中心研究,旨在评估特定多相 VLCKD 方案在超重或肥胖女性中的疗效和安全性。
在 33 名门诊女性(年龄 27-60 岁)中进行了一项多中心、前瞻性、非对照试验,这些女性超重或肥胖(BMI:30.9 ± 2.7 kg/m;腰围:96.0 ± 9.4 cm),她们开始进行 VLCKD 饮食方案(持续时间:24 周),分为四个阶段。通过评估人体测量学指标和心血管代谢标志物来评估 VLCKD 的疗效;评估肝功能和肾功能生物标志物作为安全性参数。
VLCKD 方案导致体重和 BMI(-14.6%)以及腰围(-12.4%)显著下降。在方案结束时,33.3%的参与者达到正常体重,肥胖范围的受试者从 70%减少到 16.7%。HOMA-IR 在第 2 阶段后从 3.17 ± 2.67 明显降低到 1.73 ± 1.23,此后保持不变。收缩压在第 1 阶段后下降(-3.5 mmHg),并在整个方案结束时保持不变。总胆固醇、LDL 胆固醇和甘油三酯在 VLCKD 治疗后显著降低,同时 HDL 胆固醇显著升高。肝功能、肾功能和甲状腺功能标志物没有变化,保持在参考范围内。
在超重/肥胖女性队列中进行的一项多中心 VLCKD 方案的研究结果表明,它是安全有效的,因为它可以显著改善心血管代谢参数,从而带来的益处远远超出了单纯的体重/脂肪减少。