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Recruiting NCT07130318

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

No phase Interventional Familial Mediterranean Fever Non-Alcoholic Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: exercise plus diet restriction, diet restriction.
Who it may be relevant to
Registry conditions: Familial Mediterranean Fever, Non-Alcoholic Fatty Liver Disease. Basic parameters: 30 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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)

Interventions

  • Behavioral exercise plus diet restriction
    Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. also, this group, 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)
  • Behavioral diet restriction
    Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months.

Primary outcome measures

  • aspartate transaminase [Time frame: it will be measured after 6 months]
Secondary outcome measures (9)
  • alanine transaminase [Time frame: it will be measured after 6 months]
  • body mass index [Time frame: it will be measured after 6 months]
  • waist circumference [Time frame: it will be measured after 6 months]
  • high density lipoprotein [Time frame: it will be measured after 6 months]
  • triglycerides [Time frame: it will be measured after 6 months]
  • cholesterol [Time frame: it will be measured after 6 months]
  • low density lipoprotein [Time frame: it will be measured after 6 months]
  • c reactive protein [Time frame: it will be measured after 6 months]
  • erythrocyte sedimentation rate [Time frame: it will be measured after 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • faculty of physical therapy Cairo university — Dokki

Identifiers

NCT: NCT07130318 · IRB00014233-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗