ClinicalTrials.gov record NCT07130318

Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Aerobic Exercise

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Elliptical Aerobic Exercise

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age30 years old to 55 years old
SexFemale
LocationEgypt
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized study compares a Mediterranean diet alone versus the same diet plus elliptical aerobic exercise in women with Familial Mediterranean Fever who also have non-alcoholic fatty liver. All participants continue their usual colchicine and follow the Mediterranean diet for six months; one group also does 40-minute elliptical sessions three times per week. The study measures liver enzymes and several metabolic and inflammation markers after six months.

What it is studying. The study is testing whether adding a structured aerobic exercise program (elliptical machine, 40 minutes, three times weekly for six months) to a Mediterranean diet changes liver-related tests and metabolic measurements in women with Familial Mediterranean Fever and non-alcoholic fatty liver. The primary outcome named is aspartate transaminase (a liver enzyme). Secondary measures recorded include alanine transaminase, body mass index, waist circumference, blood lipids (HDL, LDL, triglycerides, cholesterol) and inflammation markers (C-reactive protein, erythrocyte sedimentation rate).

What the researchers hope to learn. To learn whether adding regular aerobic exercise to a Mediterranean diet affects liver enzymes, body measurements, blood lipids, and inflammation markers in women with Familial Mediterranean Fever and non-alcoholic fatty liver disease.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Familial Mediterranean fever (FMF) affect liver and causes some dysfunctions including non-alcoholic fatty liver.. still exercise and diet limitation is the treatment for this case

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral
  • exercise plus diet restriction
  • diet restriction

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • familial Mediterrean fever women
  • obese women
  • women who have fatty live (non alcoholic type)

Exclusion criteria

  • cardiac patients
  • respiratory disease
  • renal disease
  • cancer

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Familial Mediterranean fever (FMF women with fatty liver) will be collected to be cateogarized to group I or group II. Every group OF FMF will contain 20 FMF women. Both groups will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. Group I will also perform elliptical aerobic exercise (this exercise will be applied for 40 minutes three times weekly and this exercise will be maintained for 6 months)

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will be randomly assigned to one of two groups and followed for six months. Both groups follow a Mediterranean diet and continue colchicine; one group also performs elliptical aerobic exercise for 40 minutes, three times weekly for six months. After the 6-month period you will have blood tests (including liver enzymes and blood lipids) and physical measurements such as body mass index and waist circumference.

How the study is structured. Randomized, parallel-group interventional trial where participants are assigned to one of two behavioral programs. Both groups follow colchicine plus a Mediterranean diet for six months; one group also follows an elliptical aerobic exercise routine (40 minutes, three times weekly). The study is single-masked and compares outcomes between the two groups after six months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 8, 2025
Primary completion
Jan 8, 2026 (estimated)
Study completion
Jan 8, 2026 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Aug 19, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Cairo University
Principal investigator
Ali Mohamed Ali ismail, lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Cairo University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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