The Study

This studied the effects of a ketogenic diet (KD) on weight loss, as well as the main risk factors for cardiovascular diseases, using overweight and obese human subjects.


The study was carried out with 311 patients recruited across Italy. The selected patients were between 30 and 69 years old and considered overweight or obese. As such, some of them already suffered from various obesity-related conditions, such as arterial hypertension (21.1%), pre-diabetes (10%), type 2 diabetes (6.4%), pharmacologically treated hypothyroidism (12.2%) or the presence of cardiovascular disease risk factors (3.2%). Patients suffering from renal impairment, major depression associated with eating disorders, serious hepatic impairment, insulin-dependent type 1 diabetes or undergoing oral anticoagulant or anti-cancer treatments were excluded from the study, as well as pregnant or breastfeeding women.

Patients were medically examined at the beginning of the study and after one month, three months and twelve months of a complex diet beginning with a KD based on high protein level and low carbohydrates and fats. Products such as fruit, dairy, cereals and vegetables were then reinserted gradually in the patients’ diet until they had a balanced Mediterranean diet based upon their respective energy expenditure. Among the patients enrolled at the beginning of the study, 82.5% completed the first month period, 71.1% completed the 3-month period and only 52% completed the whole 12-month program.


All the anthropometric variables decreased in the first three months of the diet, meaning that the patients efficiently and quickly lost weight, as well as body mass. After this initial period, they remained stable until the end of the 12-month program. It is interesting to note that the short-term weight loss was quicker for the male subjects than for the female subjects. Blood pressure parameters also improved in the first three months and remained stable afterwards.

Regarding the diabetes-related parameters, the fasting glucose level improved in the first month while the plasma glucose level improved in the first three-month period and they were both stable until the end of the study. The level of LDL cholesterol, the so-called “bad cholesterol”, and triglycerides improved in the first three months and remained stable afterwards, while the level of HDL cholesterol, the so-called “good” one, improved gradually throughout the duration of the study. Furthermore, the different liver parameters improved in the first one-month or three-month period and remained stable up to one year, while the renal parameters were not modified throughout the duration of the study.


The authors concluded that a short-term KD might be beneficial for overweight or obese patients by reducing their body weight, as well as their risk factors for cardiovascular diseases. It is interesting to note that the Mediterranean diet, following the KD period, helped maintain the benefits acquired in the short-term KD. Furthermore, this study did not find any adverse clinically relevant effects of diet modification in the participants and this diet was also well tolerated by the patients.

Study Editor

Marie-Christine Brotherton holds a Ph.D. in Cellular and Molecular Biology with specific expertise in Parasitology, Proteomics, Drug Resistance and Genomics. She also holds a MBA with a major in Corporate Social and Environmental Responsibility. She has strong experience with the scientific publication process, including author guidelines requirements, as well as with the medical and social/environmental fields. She can be reached by email at


Cicero, A. F., Benelli, M., Brancaleoni, M., Dainelli, G., Merlini, D., & Negri, R. (2015). Middle and Long-Term Impact of a Very Low-Carbohydrate Ketogenic Diet on Cardiometabolic Factors: A Multi-Center, Cross-Sectional, Clinical Study. High Blood Pressure & Cardiovascular Prevention, 1-6.