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Clinical Trials/NCT07130318
NCT07130318RecruitingNot Applicable

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

Cairo University1 site in 1 country40 target enrollmentStarted: May 8, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
aspartate transaminase

Study Overview

Brief Summary

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
30 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •cardiac patients
  • •respiratory disease
  • •renal disease

Arms & Interventions

group number 1

Experimental

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)

Intervention: exercise plus diet restriction (Behavioral)

group number 2

Active Comparator

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.

Intervention: diet restriction (Behavioral)

Outcomes

Primary Outcomes

aspartate transaminase

Time Frame: it will be measured after 6 months

it is a hepatic enzyme

Secondary Outcomes

  • erythrocyte sedimentation rate(it will be measured after 6 months)
  • alanine transaminase(it will be measured after 6 months)
  • body mass index(it will be measured after 6 months)
  • waist circumference(it will be measured after 6 months)
  • high density lipoprotein(it will be measured after 6 months)
  • triglycerides(it will be measured after 6 months)
  • cholesterol(it will be measured after 6 months)
  • low density lipoprotein(it will be measured after 6 months)
  • c reactive protein(it will be measured after 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Mohamed Ali ismail

lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

Study Sites (1)

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