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Keto diet showdown: can a Very-Low-Calorie version beat the mediterranean diet for Long-Term weight loss?

NCT ID NCT05781269

Disease control Sponsor: Istituto Auxologico Italiano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a very-low-calorie ketogenic diet (VLCKD) helps people with severe obesity and metabolic syndrome lose more weight and improve heart health over three years compared to a standard Mediterranean diet. About 100 adults aged 55-75 will be randomly assigned to one of the two diets. Researchers will track weight, blood sugar, cholesterol, blood pressure, and other health markers to see which diet works better long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome metabolic syndrome X morbid obesity Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Morbid obesity Obesity

Contacts and locations

Locations

  • Istituto Auxologico Italiano

    Milan, 20145, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.