Long Term Effect of Very-low-calories Ketogenic Diet on Weight Control and Cardiovascular Brisk Factors (KETOHEART)

Condition(s) studied

Investigational drug(s) / intervention(s)

VLCKD: VLCKD diet treatment with medical food

r-MedDiet: Mediterranean diet treatment

Study summary

The growing obesity pandemic has a major impact on global cardiovascular (CVD)-related morbidity and premature mortality, severely compromising the quality of life of those affected and significantly increasing costs for the healthcare system.

Numerous scientific evidences have demonstrated that a moderate weight loss (5-10% of the initial body weight) is already sufficient to determine the improvement of the cardiometabolic risk factors associated with overweight and obesity. With a view to obtaining a more significant weight loss in the initial stages of dietary treatment, in the last 10 years, the very low-calorie ketogenic diet (VLCKD) has become a strategy for the treatment of obesity and its comorbidities, also allowing to limit therapeutic failure and the high drop-out typical of traditional low-calorie diets.

The present study aims to study the long-term efficacy (36 months) of VLCKD in patients with severe obesity and metabolic syndrome, on weight loss, on single factors of the metabolic syndrome compared to a restrictive Mediterranean diet.

One hundred subjects with severe obesity and metabolic syndrome will be recruited and randomly assigned to VLCKD or to restrictive Mediterranean diet. Anthropometric parameters, metabolic status blood pressure, degree of arterial stiffness, prevalence and severity of snoring and OSA, cardiac systolic and diastolic function, the autonomic nervous control mode of the circulation will be evaluated at baseline, after one month and at the end of the study.

Eligibility

Primary outcome measure(s)

• change from baseline body weight at 36 months — baseline, 36 month
  body weight measured to the nearest 0.1 Kg with a calibrated weight scale
• change from baseline fasting glucose in mg/dl at 36 months — baseline, 36 month
  blood chemistry tests for the evaluation of blood glucose
• change from baseline HDL cholesterol, triglycerides at 36 months — baseline, 36 month
  blood chemistry tests for the evaluation of HDL cholesterol, triglycerides
• change from baseline blood pressure in mmHg at 36 months — baseline, 36 months
  measurement of systolic and diastolic pressure using using an aneroid sphygmomanometer with the appropriate cuff
• change from baseline distensibility of the carotid, radial and femoral arteries in m/s at 36 months — baseline, 36 months
  arterial stiffness measured by Pulse Wave Velocity carotid-femoral
• change from baseline waist circumference in cm at 36 months — baseline, 36 months
  waist circumference using a non-stretch tape to the nearest 0.5 cm

Trial sites (1)

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