NCT05781269Active, not recruiting
Long Term Effect of Very-low-calories Ketogenic Diet on Weight Control and Cardiovascular Brisk Factors (KETOHEART)
Metabolic Syndrome and Severe Obesity: Randomized Nutritional Trial to Study Long Term Effect of Very-low-calories Ketogenic Diet (VLCKD) on Weight Control and Cardiovascular Risk Factors
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 26 Feb 2023
- Start date
- 20 Feb 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Istituto Auxologico Italiano
- Diseases
- Obesity
- NCT number
- NCT05781269
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 20 Feb 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute heart failure, transient ischemic attack or stroke in the previous 12 months
- History of previous pancreatitis
- Ongoing pharmacological therapy with topiramate, zonisamide, acetazolamide, valproic acid- - ----- - chronic therapy with diuretics (which cannot be suspended even temporarily), SGLT2 -inhibitors (due to the risk of euglycemic diabetic ketoacidosis) and beta blockers.
Other illness
- Autoimmune diseases (TCA relative contraindication)
- Stubborn constipation or history of intestinal occlusions/subocclusions
- Type 1 diabetes
- History of previous cancer within the first 5 years of follow-up
- Active eating disorder or history of bulimia and anorexia nervosa, active severe binge eating,
- Psychiatric disorders not in compensation or at risk of decompensation
Lab values
- Long QT \>0.44 s, known arrhythmia, cardiomyopathy, heart failure (NYHA classes III-IV)
- chronic renal insufficiency (creatinine \>1.5 and/or creatinine clearance \<45 mL/min), history -positive for previous episodes of acute renal failure
- Hepatic insufficiency and/or ALT and AST \> 3 times the upper limit
Other
- Hypokalemia, hypernatremia
- Persistent diarrhea
- Acidosis (metabolic or respiratory) even if compensated
- Pregnancy or breastfeeding
- Symptomatic cholelithiasis
- Alcoholism, substance abuse
- Known primary pathologies of carnitine metabolism or beta oxidation
Who the study is looking for
- Men between the ages of 55 and 75 with no documented history of CVD (except NYHA class I and II heart failure or valvular heart disease)
- Women aged 60 to 75, with no documented history of CVD (except NYHA class I and II heart failure or valvular heart disease)
- BMI ≥30 and \<50kg/m2-At least three positive factors for metabolic syndrome according to the harmonized definition (IDF --------2009)
- Availability to be followed in the follow-up at the San Michele Hospital IRCCS Istituto Auxologico Italiano in Milan
Age in the registry: 55 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Auxologico Italiano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.