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Which ketogenic diet works best? new study compares meal replacements vs. natural foods

NCT ID NCT07389122

Disease control Sponsor: University of Bologna 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how well adults with obesity or complicated overweight could stick to different very low-calorie ketogenic diets (VLCKD) in a real-world clinic. Participants chose one of four diet plans, ranging from all-natural foods to all meal replacements, and followed a 26-week program. The goal was to see which diet had the best adherence, fewest side effects, and highest satisfaction, which could help personalize weight management strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
very low-calorie ketogenic diet (VLCKD) with varying protein sources (natural foods vs. meal replacements)
What this could lead to
If successful, this study could help doctors and patients choose the most tolerable and effective ketogenic diet plan for weight loss and metabolic health.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by personal preference. It is also small and single-center, limiting how widely the findings can be applied.

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.

Participants

110 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 2025

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.

Who is studied

The target population includes all consecutive individuals who, in the context of routine clinical practice, meet the eligibility criteria for VLCKD therapy.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Obesity with or without comorbidities (BMI ≥ 30 kg/m²) OR * Overweight with comorbidity of MASLD (BMI 25.0-29.9 kg/m²) PLUS * Previous unsuccessful attempt at a prescribed hypocaloric diet Exclusion Criteria: * Age \< 18 years * Pregnancy * Breastfeeding * Moderate or severe kidney failure * Cardiovascular diseases: heart failure (NYHA III-IV), unstable angina, acute coronary syndrome or stroke within the past 12 months, paroxysmal atrial fibrillation, any type of atrioventricular block, left bundle branch block * Liver diseases: Child-Pugh C, elevated transaminases with AST or ALT ≥ 5 times the upper limit of normal, INR ≥ 1.5, total bilirubin ≥ 2 mg/dL * Diabetes: type 1 diabetes mellitus, type 2 diabetes mellitus with insufficient pancreatic endocrine reserve (C-peptide \< 0.8 ng/mL), type 2 diabetes mellitus on multiple daily insulin injections * Last attempt of VLCKD outside the research protocol within the past 12 months * Eating disorders: anorexia nervosa, bulimia nervosa, binge eating disorder * Psychiatric comorbidities, alcohol or substance dependence * Frail elderly patients

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Conditions

The condition(s) this trial relates to.

Insulin Resistance metabolic dysfunction-associated steatotic liver disease Obesity obesity disorder Overweight type 2 diabetes mellitus Weight Loss

As listed by the trial registrant

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

Insulin resistance Masld/mash (metabolic dysfunction-associated steatotic liver disease / metabolic dysfunction-associated steatohepatitis) Obesity & overweight Type 2 diabetes

Contacts and locations

Locations

  • S.Orsola-Malpighi Hospital-University of Bologna

    Bologna, BO, 40138, Italy

More trials for these conditions

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