title: Middle and Long-Term Impact of a Very Low-Carbohydrate Ketogenic Diet on Cardiometabolic Factors: A Multi-Center, Cross-Sectional, Clinical Study.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, University of Bologna, U.O. Medicina Interna Borghi-Via Albertoni, 15, Bologna, Italy. afgcicero@cardionet.it.
authors.forename: Arrigo F G
authors.initials: AF
authors.lastname: Cicero
authors.affiliation: Santa Chiara Foundation, Lodi, Italy.
authors.forename: Maddalena
authors.initials: M
authors.lastname: Benelli
authors.affiliation: National Public Health System, Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Brancaleoni
authors.affiliation: National Public Health System, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Dainelli
authors.affiliation: National Public Health System, Rome, Italy.
authors.forename: Desiré
authors.initials: D
authors.lastname: Merlini
authors.affiliation: National Public Health System, Rome, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Negri
mesh_terms: D050154:Adiposity; D000328:Adult; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure; D003430:Cross-Sectional Studies; D050528:Diet, Carbohydrate-Restricted; D018752:Diet, Fat-Restricted; D055423:Diet, Ketogenic; D004044:Dietary Proteins / Q000008:administration & dosage; D005260:Female; D058006:General Practice; D006801:Humans; D007558:Italy; D008055:Lipids / Q000097:blood; D008297:Male; D024821:Metabolic Syndrome / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000175:diagnosis / Q000178:diet therapy* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D055105:Waist Circumference; D015431:Weight Loss
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D004044:Dietary Proteins; D008055:Lipids
keywords: Cardiovascular risk factors; General practice; Ketogenic diet; Safety