Middle and Long-Term Impact of a Very Low-Carbohydrate Ketogenic Diet on Cardiometabolic Factors: A Multi-Center, Cross-Sectional, Clinical Study.

Introduction: Obesity is a constantly growing illness in developed countries and it is strictly related to cardiovascular (CV) diseases, i.e. the main cause of mortality throughout industralised areas.

Aim: to test the ability of trained general physician to safely and effectively prescribe a very-low carbohydrate ketogenic (VLCK) diet in clinical practice, with a specific attention to the effect of this approach on overweight related CV risk factors (anthropometric measures) blood pressure, lipid levels, glucose metabolism).

Methods: The study has been carried out on a group of 377 patients scattered across Italy and monitored during 1 year. The proposed VLCK diet is a nutritional regimen characterized by low-fat and low- carbohydrates formulations and a protein content of 1.2/1.5 g/kg of ideal body weight, followed by a period of slow re-insertion and alimentary re-education.

Results: All the predetermined goals-namely safety, reduction of body weight and CV risk factors levels-have been reached with a significant reduction of body weight (from baseline to 4 weeks (-7 ± 5 kg, p < 0.001), from 4 to 12 weeks (-5 ± 3 kg, p < 0.001), no changes from 12 weeks to 12 months; waistline (from baseline to 4 weeks (-7 ± 4 cm, p < 0.001), from 4 to 12 weeks (-5 ± 7 cm, p < 0.001), no changes from 12 weeks to 12 months; fatty mass (from baseline to 4 weeks (-3.8 ± 3.8 %, p < 0.001), from 4 to 12 weeks (-3.4 ± 3.5 %, p < 0.001), no changes from 12 weeks to 12 months; SBP from baseline to 3 months (-10.5 ± 6.4 mmHg, p < 0.001), no further changes after 1 year of observation).

Conclusion: the tested VLCD diet suggested by trained general physicians in the setting of clinical practice seems to be able to significantly improve on the middle-term a number of anthropometric, haemodynamic and laboratory with an overall good tolerability.