ABSTRACT
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.
Subject(s)
Diet, Carbohydrate-Restricted , Diet, Ketogenic , Metabolic Syndrome/prevention & control , Obesity/diet therapy , Adiposity , Adult , Biomarkers/blood , Blood Glucose/metabolism , Blood Pressure , Cross-Sectional Studies , Diet, Fat-Restricted , Dietary Proteins/administration & dosage , Female , General Practice , Humans , Italy , Lipids/blood , Male , Metabolic Syndrome/blood , Metabolic Syndrome/diagnosis , Metabolic Syndrome/physiopathology , Middle Aged , Obesity/blood , Obesity/diagnosis , Obesity/physiopathology , Time Factors , Treatment Outcome , Waist Circumference , Weight LossABSTRACT
OBJECTIVES: We planned to carry out a pilot study to evaluate the efficacy and safety as an antihypercholesterolemic agent of a brand dietary supplement made of Monascus purpureus titrated extract, octacosanols and niacin on 111 Caucasian patients with low cardiovascular disease risk (<20% by Framingham algorithms), comparing them with the antihypercholesterolemic effect of a low dosage of Pravastatin on 20 subjects with similar risk profile. RESULTS: In our study, the tested dietary supplement determined a significant decrease of Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG) in moderately hypercholesterolemic subjects without clinically relevant change in liver and muscular toxicity markers. The reduction of LDL-C reached the 20%, and it is similar to that obtained with a well-known effective statin like Pravastatin. CONCLUSIONS: Further long-term and double blind evaluation have to be carried out before to infer the observed results, however it appears that the studied dietary supplements could be a safe and efficacious antihypercholesterolemic agent for patients at low risk for cardiovascular diseases.
