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Diet showdown: keto vs. mediterranean for fibromyalgia relief

NCT ID NCT07517757

Symptom relief Sponsor: Universita degli Studi di Genova 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test whether different diets—a very low-calorie ketogenic diet, a Mediterranean diet, or a Mediterranean diet with added probiotics—can reduce pain and improve quality of life in women with fibromyalgia who are overweight or mildly obese. Researchers will track pain, sleep, mood, and gut health over 12 weeks. The goal is to find a practical, non-drug approach to managing fibromyalgia symptoms.

What this could mean

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

Active substance
dietary interventions (very low-calorie ketogenic diet, Mediterranean diet, and Mediterranean diet with probiotics)
What this could lead to
If successful, this could point toward a simple, drug-free way to reduce pain and improve sleep, mood, and daily function in women with fibromyalgia.
What could go wrong
This is a small, early-stage study with only 90 participants, so results may not apply to everyone. Dietary changes can be hard to stick with, and the effects may vary from person to person.

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 90 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

18 to 65 years

Sex

Female participants only

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: * Adult female patients with fibromyalgia, aged ≤ 65 years, who are overweight or obese (BMI 24.9 \< ≤34.9 kg/m2); * Patients able to independently provide their written informed consent to participate in the study; * Patients motivated to participate in the project and able to independently manage the dietary plans provided for in the study. Exclusion Criteria: * Lack of signature on informed consent form * Age \< 18 and \> 65 years * Male gender * Patients with food allergies or celiac disease, type 1 diabetes mellitus and autoimmune forms of diabetes mellitus or with severe pancreatic beta cell dysfunction, undergoing treatment with SGLT2 inhibitors, with recent cardiovascular or cerebrovascular events, liver failure, moderate or severe renal failure, respiratory failure, episodes of gout, kidney stones, electrolyte disturbances, NYHA class III-IV heart failure, unstable angina, cardiac arrhythmias or myocardial infarction within the last 12 months, severe depression or any other psychiatric illness, drug, narcotic or alcohol abuse, frail patients, pregnancy and/or breastfeeding, patients about to undergo surgery or invasive procedures, rare diseases (porphyria, carnitine deficiency, carnitine palmitoyltransferase, carnitine acylcarnitine translocase and pyruvate carboxylase, mitochondrial beta oxidation disorders), treatment with diuretics. * Use of prebiotics and/or probiotics not included in the study, or other dietary supplements in the month prior to enrollment * Antibiotic treatment less than 3 months prior to enrollment * Infections at the time of enrollment or any chronic gastrointestinal disorder (e.g., Crohn's disease) * Significant eating problems (e.g., dysphagia).

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Conditions

The condition(s) this trial relates to.

fibromyalgia Obesity

As listed by the trial registrant

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

Fibromyalgia (FM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Internal and Medical Specialities (university of Genoa)

    Genova, Genova, 16132, Italy

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