Diet showdown: keto vs. mediterranean for fibromyalgia relief
NCT ID NCT07517757
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
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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
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Department of Internal and Medical Specialities (university of Genoa)
Genova, Genova, 16132, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ear stimulation may tame both fibromyalgia pain and PTSD
- Social media support groups may ease loneliness in fibromyalgia
- Teaching the brain about pain may boost exercise benefits for chronic pain sufferers
- AI coach could help fibromyalgia patients exercise at home
- Brain zaps might quiet fibromyalgia pain without drugs