Reduction of Cardio-Metabolic Risk and Body Weight through a Multiphasic Very-Low Calorie Ketogenic Diet Program in Women with Overweight/Obesity: A Study in a Real-World Setting.

Elena Tragni,Manuela Casula,Paolo Magni,Massimiliano Ruscica,Alfonso Santelia,Alberico L Catapano,Chiara Macchi,Luisella Vigna

doi:10.3390/nu13061804

Abstract

Background: 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. Methods: 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/m2; 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. Results: 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. Conclusions: 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.

Highlights

Prevention and treatment of obesity and its cardio-metabolic complications are growing public health problems worldwide since this condition affects a relevant part of the world population across both genders and all ages and ethnic groups, and its prevalence is maintained or even accelerated in most industrialized countries [1,2,3,4]
The study was designed as a multi-center, prospective, uncontrolled trial in a real-life setting and included Caucasian outpatient women with overweight or obesity and some features of the metabolic syndrome, including increased waist circumference (WC) and pharmacologically controlled arterial hypertension [25]; 11/33 subjects were on pharmacological therapy for arterial hypertension (Table S1)
The efficacy data obtained show that the very low-calorie ketogenic diets (VLCKD) program resulted in a significant reduction (−14.6%) of body weight and BMI, which is greater than the 10% threshold proposed by the obesity guidelines [15]

Summary

Introduction

Prevention and treatment of obesity and its cardio-metabolic complications are growing public health problems worldwide since this condition affects a relevant part of the world population across both genders and all ages and ethnic groups, and its prevalence is maintained or even accelerated in most industrialized countries [1,2,3,4]. The prevalence of obesity has reached epidemic proportions, and, the identification of effective lifestyle tools, including nutritional ones [5], able to produce significant weight loss and to maintain it over time is mandatory, in order to limit its progression from the uncomplicated stage to that characterized by cardiovascular and metabolic complications [6,7,8], as well as oncologic diseases [9]. In this context, cardiovascular disease (CVD) risk and unhealthy lifestyle habits [10] are often underdiagnosed and undertreated, highly contributing to atherosclerotic CVD (ASCVD) prevalence [11].

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Conclusion