Long-term effects of a very low-calorie ketogenic diet on weight and heart health
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
This study is testing if a very low-calorie ketogenic diet can help people aged 55 to 75 with severe obesity and metabolic syndrome lose weight and improve their heart health over three years compared to a Mediterranean diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05781269 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term efficacy of a very low-calorie ketogenic diet (VLCKD) over 36 months in individuals aged 55 to 75 with severe obesity and metabolic syndrome. Participants will be randomly assigned to either the VLCKD group or a restrictive Mediterranean diet group, with the aim of achieving a significant weight loss of 20% from their initial weight. The study will evaluate changes in weight, metabolic parameters, cardiovascular function, and sleep quality, comparing the outcomes between the two dietary approaches. Medical food products will be provided to participants in the VLCKD group to support their dietary adherence.
Who should consider this trial
Good fit: Ideal candidates are men aged 55-75 and women aged 60-75 with a BMI between 30 and 50 and at least three factors of metabolic syndrome.
Not a fit: Patients with a history of severe cardiovascular issues, certain metabolic disorders, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective dietary intervention for weight loss and improved cardiovascular health in obese individuals.
How similar studies have performed: Other studies have shown promising results with ketogenic diets for weight loss and metabolic improvements, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Long QT \>0.44 s, known arrhythmia, cardiomyopathy, heart failure (NYHA classes III-IV) * Hypokalemia, hypernatremia * Persistent diarrhea * Acidosis (metabolic or respiratory) even if compensated * Acute heart failure, transient ischemic attack or stroke in the previous 12 months * Pregnancy or breastfeeding * chronic renal insufficiency (creatinine \>1.5 and/or creatinine clearance \<45 mL/min), history -positive for previous episodes of acute renal failure * Autoimmune diseases (TCA relative contraindication) * History of previous pancreatitis * Symptomatic cholelithiasis * Hepatic insufficiency and/or ALT and AST \> 3 times the upper limit * 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 * Alcoholism, substance abuse * 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. * Known primary pathologies of carnitine metabolism or beta oxidation
Where this trial is running
Milano
- Istituto Auxologico Italiano — Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Luisa Gilardini, MD
- Email: l.gilardini@auxologico.it
- Phone: +3902619112561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.