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Ketogenic diet vs mediterranean diet: which better reshapes metabolism?

NCT ID NCT05275608

Disease control Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers compare a very low calorie ketogenic diet with a Mediterranean-style low-calorie diet in 40 adults who have type 2 diabetes, obesity, and non-alcoholic fatty liver disease. Participants follow one of the two diets for several weeks. The study measures changes in weight, blood sugar, cholesterol, liver enzymes, gut bacteria, and body composition to see how each diet affects metabolism and inflammation.

What this could mean

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

Active substance
a very low calorie ketogenic diet with meal-replacement supplements
What this could lead to
If the ketogenic diet helps, it could offer a structured way to improve blood sugar, weight, and liver health in people with metabolic syndrome.
What could go wrong
This is a small pilot study of 40 people, so any differences may be chance or may not apply to others. Very low calorie diets can cause fatigue, constipation, or nutrient gaps and are hard to stick with.

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 40 people

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

Started

Nov 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

25 to 65 years

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: * Age 25-65 * BMI 30-40 mg/m2 * NAFLD * DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, basal insulin) and HbA1c \> 7 and \< 10 %. Exclusion Criteria: * Secondary obesity due to genetic or endocrinologic causes. * renal disease with eGFR \< 45 mL/min/1.73m2 or macroalbuminuria or calculosis * insulin basal + bolus or HbA1c% \>10.0% * Other types of DM * ipopituitarism or adrenal insufficiency * antibiotics use less than 3 months before the first visit

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome metabolic dysfunction-associated steatotic liver disease metabolic syndrome X Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus type 2 Metabolic syndrome Non-alcoholic fatty liver disease Obesity

Contacts and locations

Locations

  • : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont

    Novara, Italy, 28100, Italy

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