Mediterranean diet with or without aerobic exercise for women with familial Mediterranean fever and fatty liver
Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Elliptical Aerobic Exercise
This trial will test whether adding regular aerobic exercise to a Mediterranean diet helps women with familial Mediterranean fever who have non-alcoholic fatty liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Dokki, Giza Governorate) |
| Trial ID | NCT07130318 on ClinicalTrials.gov |
What this trial studies
Forty obese women with familial Mediterranean fever and non-alcoholic fatty liver will be assigned to two groups of 20. Both groups will continue colchicine and follow a Mediterranean diet for six months, while the intervention group also performs elliptical aerobic exercise for 40 minutes three times weekly. Liver fat and related laboratory and clinical measures will be collected at baseline and after six months to compare changes between groups. The study is conducted at the Faculty of Physical Therapy, Cairo University.
Who should consider this trial
Good fit: Obese women diagnosed with familial Mediterranean fever who have non-alcoholic fatty liver and are medically cleared to undertake aerobic exercise.
Not a fit: Women without fatty liver, or those with cardiac, respiratory, renal disease, or active cancer (who are excluded or cannot safely exercise), are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding aerobic exercise could reduce liver fat and improve liver-related measures and overall health in affected women.
How similar studies have performed: Mediterranean diet and aerobic exercise have improved non-alcoholic fatty liver in other populations, but applying this combination specifically in women with FMF is novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dokki, Giza Governorate
- faculty of physical therapy Cairo university — Dokki, Giza Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Ali MA Ismail, lecturer — Cairo University
- Study coordinator: Ali MA Ismail, lecturer
- Email: ali.mohamed@pt.cu.edu.eg
- Phone: 01005154209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.