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

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.

Keywords: cardiovascular risk; insulin resistance; nutraceutical; obesity; very-low calorie ketogenic diet.

Figure 1

Outline of the VLCKD program. The program included 4 separate phases, with a total duration of 24 weeks.

Figure 2

CONSORT statement flow diagram.

Figure 3

Effect of the VLCKD program on BMI, waist circumference and waist/hip ratio. (A) BMI changes during the 24-week program; (B) waist circumference during the 24-week program; (C) waist/hip ratio during the 24-week program. Data are mean ± SD. (*) p < 0.05 and (**) p < 0.001: p-value across consecutive visits. (▲) p < 0.05 and (▲▲) p < 0.001: p-value for trend.

Figure 4

Effect of the VLCKD program on the BMI classes distribution. The relative % distribution of patients in the normal weight (<25.0 kg/m²), overweight (<25.0–29.9 kg/m²) and obese (>30 kg/m²) BMI classes, over the 24-week VLCKD program, is reported. V, visit.